FORMULA: The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00138645
• Collaborator: Sunny Health Co., Ltd. (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes	Behavioral: MicroDiet; Behavioral: Healthy Diet	Phase 4

Detailed Description

In recent decades, the prevalence of overweight and obesity has increased dramatically in developed countries. Obesity is associated with diseases such as diabetes, cardiovascular disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of initial body weight) significantly improve health and improve disease status. Recent evidence suggests that the use of supplements or meal replacements promotes greater weight loss than isocaloric food-based diets. In addition, diets that are high in protein are associated with greater ratings of satiety and reduced food intake, as well as greater weight loss, compared to lower protein diets.

The purpose of the proposed study is to test the effect of a partial supplement diet on body weight, body composition, and biomarkers for disease compared to an isocaloric diet that consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35) participants will participate in this six-month study. The primary outcome variable is body weight loss and the secondary outcome variables include body composition, blood pressure, lipids, and subjective ratings of satiety.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MicroDiet Participants randomized to the MicroDiet group (1200 kcal/day) will be instructed by a Registered Dietitian to consume (one shake and 3 cookies; 240 kcal) for two meals each day for Months 1 through 3. They will be provided with meal plans for the meal that they do not replace with MicroDiet. During Months 4 through 6, participants in the MicroDiet group will be instructed to replace one meal per day with MD (the energy content of the meal plan will still be 1200 kcal/day). Participants will also be encouraged to eat or drink MD for snacks. The rest of the diet will consist of healthy foods, as outlined above. To help participants adhere to the MicroDiet regimen, they will meet with a registered dietitian for one hour at Week 0 and 30 minutes at Weeks 2 and 4, and every month thereafter.	Behavioral: MicroDiet; MicroDiet
Active Comparator: Healthy Diet Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet. The Healthy Diet will consist of the same foods that are used in the meal plans for the MicroDiet group. The Healthy Diet group will be instructed not to use meal replacements such as shakes (e.g., Slim Fast®), nutrition bars (e.g., Balance Bar®), or portion-controlled meals (e.g., Healthy Choice entrees).	Behavioral: Healthy Diet; Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements

Outcome Measures

Primary Outcome Measures

1. Body Weight Loss (kg and Percent) at Months 3 and 6 [April 2005 to May 2006]

2. Percent Change in Body Weight (Completers). [24 weeks]

   Percent change in body weight from baseline to week 24(completers).

Secondary Outcome Measures

1. Change in Body Composition at Months 3 and 6 [April 2005 to May 2006]

2. Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6 [April 2005 to May 2006]

3. Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6 [April 2005 to May 2006]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female gender; of all ethnic backgrounds.

• Healthy person who has not been diagnosed with diabetes, cardiovascular illness, renal, hepatic or other chronic diseases

• 17 years and < 66 years of age

• Body mass index (BMI; kg/m2) between 25 and 35

• For females with the potential to bear children, they meet one of the following criteria:

• They are willing to use an acceptable method of birth control (e.g., oral contraceptive tablets, implanted contraceptive hormones, Depo-Provera® contraceptive injections, intrauterine devices, prophylactic condoms with spermicide, contraceptive diaphragms with spermicide, cervical caps with spermicide), or are in a monogamous relationship with a partner who has had a vasectomy.

• They are sexually abstinent and intend to continue this practice, at least for the duration of the study.

Exclusion Criteria:

• 65 years and < 18 years of age

• Regular use of medications other than birth control, vitamins or hormone replacement therapy

• Diabetes mellitus (fasting blood sugar [FBS] > 126); persons with impaired glucose tolerance (FBS 100-125) may be admitted to the study.

• Use of tobacco products

• Depression or mental illness requiring treatment or medication within the last six months

• For women, pregnancy, breast feeding, postpartum < 6 months, planning a pregnancy during the study, or are not using an acceptable method of contraception

• Use of medications or herbal supplements that affect appetite or body weight for the previous three months

• Patients requiring restriction of protein intake

• Impaired kidney function (creatinine > 1.5) or liver function (liver enzymes > 3 times the upper limits of normal)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Sunny Health Co., Ltd.

Investigators

• Principal Investigator: Corby K. Martin, Ph.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corby K. Martin, Associate Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00138645
• Other Study ID Numbers: PBRC 25004
• First Posted: Aug 30, 2005
• Last Update Posted: Feb 8, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Body Weight; Body Weight Changes

Study Results

Participant Flow

Arm/Group Title	MicroDiet	Healthy Diet
Arm/Group Description	MicroDiet	Healthy Diet
Period Title: Overall Study
STARTED	30	30
COMPLETED	24	23
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	MicroDiet	Healthy Diet	Total
Arm/Group Description	MicroDiet	Healthy Diet	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (11.4)	43 (11.4)	42 (11.4)
Sex: Female, Male (Count of Participants)
Female	26 86.7%	25 83.3%	51 85%
Male	4 13.3%	5 16.7%	9 15%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Body Weight Loss (kg and Percent) at Months 3 and 6
Time Frame	April 2005 to May 2006

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	Change in Body Composition at Months 3 and 6
Time Frame	April 2005 to May 2006

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Time Frame	April 2005 to May 2006

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
Time Frame	April 2005 to May 2006

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

Title	Percent Change in Body Weight (Completers).
Description	Percent change in body weight from baseline to week 24(completers).
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MicroDiet	Healthy Diet
Arm/Group Description	MicroDiet	Healthy Diet
Measure Participants	24	23
Least Squares Mean (Standard Error) [change in percent:baseline body weight]	7.3 (1.3)	7.0 (1.3)

Adverse Events

Arm/Group Title	MicroDiet		Healthy Diet
Arm/Group Description	Participants randomized to the MicroDiet		participants randomized to the low-calorie diet.
All Cause Mortality
	MicroDiet		Healthy Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MicroDiet		Healthy Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	MicroDiet		Healthy Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.