Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects

• Sponsor: Louisville Metabolic and Atherosclerosis Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01260272
• Collaborator: California Raisin Marketing Board (Other)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factors	Other: Alternative Snack Comparator; Other: Raisins	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alternative Snack Group This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables	Other: Alternative Snack Comparator; Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers
Experimental: Raisin Group This group will receive raisins to consume three times a day with meals	Other: Raisins; Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Outcome Measures

Primary Outcome Measures

1. Percent Change in Postprandial Glucose Levels [12 weeks]

   Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12

2. Percent Change in Fasting Glucose Levels [12 weeks]

   Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12

3. Percent Change in Body Weight [12 weeks]

   Raisin versus snacks: percent change in body weight from baseline to week 12

Secondary Outcome Measures

1. Change in Systolic Blood Pressure [12 weeks]

   Raisin versus snacks: change in systolic blood pressure from baseline to week 12

2. Change in Diastolic Blood Pressure [12 weeks]

   Raisin versus snacks: change in diastolic blood pressure from baseline to week 12

3. Change in Hemoglobin A1c [12 weeks]

   Raisin versus snacks: change in hemoglobin A1c from baseline to week 12

4. Change in Waist Circumference [12 weeks]

   Raisin versus snacks: change in waist circumference from baseline to week 12

5. Change in High Density Lipoprotein Cholesterol Levels [12 weeks]

   Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Are generally healthy men and women older than 18 years of age.

2. Are willing and able to undergo the informed consent process.

3. Have body mass index (BMI) from 25.0 to 34.9 kg/m².

4. Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.

5. Have blood pressure > 120 mmHg systolic or > 80 mmHg diastolic.

6. Are willing to notify the research staff of any change in their medical health & concomitant medications/supplements during the course of the clinical trial.

Exclusion Criteria:

1. Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.

2. History of > one "food allergy."

3. Weight loss of > 5 pounds in last 2 months

4. Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.

5. Blood pressure >160 mmHg systolic or >100 mmHg diastolic.

6. Fasting serum lipoprotein values of: LDL-cholesterol, >160 mg/dl or triglycerides,

500 mg/dl.

1. Creatinine level > 1.5 times the upper range of normal.

2. Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)

3. Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.

4. Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.

5. Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.

6. Is pregnant, breastfeeding or plans to become pregnant during the next three months.

7. Is an employee or immediate family member of the research staff.

8. Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.

9. Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.

10. Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.

11. Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.

12. History of severe or uncontrolled depression based on Principal Investigator.

13. Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.

14. Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.

15. History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.

16. History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.

17. History of organ transplant.

18. History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).

19. Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.

20. Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.

21. Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.

22. Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.

23. Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.

24. Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.

25. Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.

26. Reasonable life-expectancy of less than 2 years.

27. Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky	United States	40213

Sponsors and Collaborators

• Louisville Metabolic and Atherosclerosis Research Center
• California Raisin Marketing Board

Investigators

• Principal Investigator: Harold E. Bays, MD, Louisville Metabolic and Atherosclerosis Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Harold E. Bays, Principal Investigator, Louisville Metabolic and Atherosclerosis Research Center
• ClinicalTrials.gov Identifier: NCT01260272
• Other Study ID Numbers: 001
• First Posted: Dec 15, 2010
• Last Update Posted: Apr 29, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Harold E. Bays, Principal Investigator, Louisville Metabolic and Atherosclerosis Research Center: Cardiovascular; Risk Factors; Cardiovascular Disease; Glucose; Blood Pressure; BMI; Weight; Waist Circumference

Study Results

Participant Flow

Recruitment Details	Recruitment for this study started around Dec 2010 and ended around April 2011. Subjects were selected from the PI's contact database and from advertisements
Pre-assignment Detail	Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Period Title: Overall Study
STARTED	17	32
COMPLETED	15	30
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Alternative Snack Group	Raisin Group	Total
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.	Total of all reporting groups
Overall Participants	17	32	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 76.5%	20 62.5%	33 67.3%
>=65 years	4 23.5%	12 37.5%	16 32.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.1 (1)	60.3 (1)	60.57 (1)
Sex: Female, Male (Count of Participants)
Female	6 35.3%	19 59.4%	25 51%
Male	11 64.7%	13 40.6%	24 49%
Region of Enrollment (participants) [Number]
United States	17 100%	32 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Postprandial Glucose Levels
Description	Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	15	28
Mean (Standard Error) [Percent change from baseline]	6.34 (7.4)	-9.83 (3.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.033
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Raisin versus snacks: change in systolic blood pressure from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	14	30
Mean (Standard Error) [mmHg]	1.71 (2.43)	-4.83 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.0468
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Change in Diastolic Blood Pressure
Description	Raisin versus snacks: change in diastolic blood pressure from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	15	31
Mean (Standard Error) [mmHg]	-1.87 (2.14)	-5.16 (1.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.2114
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Change in Hemoglobin A1c
Description	Raisin versus snacks: change in hemoglobin A1c from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	14	30
Mean (Standard Error) [Percent change from baseline]	-.04 (0.04)	-0.12 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.1727
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Percent Change in Fasting Glucose Levels
Description	Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	14	31
Median (95% Confidence Interval) [Percent change from baseline]	1.5	1.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.7498
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Primary Outcome

Title	Percent Change in Body Weight
Description	Raisin versus snacks: percent change in body weight from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	14	31
Mean (Standard Error) [Percent change from baseline]	-0.67 (0.47)	0.16 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.2615
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Change in Waist Circumference
Description	Raisin versus snacks: change in waist circumference from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	14	29
Mean (Standard Error) [cm]	-1.59 (0.52)	-2.02 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.6915
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Change in High Density Lipoprotein Cholesterol Levels
Description	Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Arm/Group Title	Alternative Snack Group	Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	This group will receive raisins to consume three times a day with meals Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Measure Participants	13	30
Mean (Standard Error) [Percent change from baseline]	0.62 (3.15)	-5.63 (2.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative Snack Group, Raisin Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1060
	Comments	Apriori threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Arm/Group Title	Alternative Snack Group		Raisin Group
Arm/Group Description	This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers		This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
All Cause Mortality
	Alternative Snack Group		Raisin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alternative Snack Group		Raisin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Alternative Snack Group		Raisin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/17 (29.4%)		20/32 (62.5%)
Cardiac disorders
Worsening hypertension	1/17 (5.9%)	1	1/32 (3.1%)	1
Endocrine disorders
Diabetes Mellitus	0/17 (0%)	0	1/32 (3.1%)	1
Gastrointestinal disorders
Excess Gas	0/17 (0%)	0	1/32 (3.1%)	1
Increased frequency of stools	0/17 (0%)	0	1/32 (3.1%)	1
Indigestion	0/17 (0%)	0	1/32 (3.1%)	1
Constipation	0/17 (0%)	0	1/32 (3.1%)	1
Diarrhea	2/17 (11.8%)	2	2/32 (6.3%)	2
Nausea	0/17 (0%)	0	2/32 (6.3%)	2
Abdominal Pain	0/17 (0%)	0	2/32 (6.3%)	2
Worsening heartburn	0/17 (0%)	0	1/32 (3.1%)	1
Xerostomia	0/17 (0%)	0	1/32 (3.1%)	1
General disorders
Allergic Rhinitis	0/17 (0%)	0	1/32 (3.1%)	1
Fluid retention	0/17 (0%)	0	1/32 (3.1%)	1
Flu-like symptoms	0/17 (0%)	0	1/32 (3.1%)	1
Vertigo	0/17 (0%)	0	1/32 (3.1%)	1
Pyrexia	1/17 (5.9%)	1	0/32 (0%)	0
Hepatobiliary disorders
Elevated liver enzymes	0/17 (0%)	0	1/32 (3.1%)	1
Infections and infestations
Sinusitis	0/17 (0%)	0	2/32 (6.3%)	2
Injury, poisoning and procedural complications
Puncture wound	1/17 (5.9%)	1	0/32 (0%)	0
Posterior head pain related to trauma	0/17 (0%)	0	1/32 (3.1%)	1
Metabolism and nutrition disorders
Decreased hunger	0/17 (0%)	0	1/32 (3.1%)	1
Musculoskeletal and connective tissue disorders
Muscle spasm	1/17 (5.9%)	1	0/32 (0%)	0
Left ankle pain	0/17 (0%)	0	1/32 (3.1%)	2
Strained muscle	0/17 (0%)	0	1/32 (3.1%)	1
Effusion to right elbow	0/17 (0%)	0	1/32 (3.1%)	1
Costochondritis	0/17 (0%)	0	1/32 (3.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine mass	0/17 (0%)	0	1/32 (3.1%)	1
Renal and urinary disorders
Bladder infection	0/17 (0%)	0	1/32 (3.1%)	1
Reproductive system and breast disorders
Intermittent cough	1/17 (5.9%)	1	0/32 (0%)	0
Chest congestion	1/17 (5.9%)	1	0/32 (0%)	0
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection	0/17 (0%)	0	4/32 (12.5%)	4
Bronchitis	0/17 (0%)	0	1/32 (3.1%)	1
Skin and subcutaneous tissue disorders
Contact dermatitis	0/17 (0%)	0	2/32 (6.3%)	2
Contusion	1/17 (5.9%)	1	0/32 (0%)	0
Vascular disorders
Brain hemorrhage	0/17 (0%)	0	1/32 (3.1%)	1

Limitations/Caveats

This was a single research site pilot study, which would benefit from a larger study, or at least, a similar confirmatory study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.