The DEB Pilot Study

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03190993
• Collaborator: Corby K. Martin (Other), Owen T. Carmichael (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Physiological Phenomena; Obesity	Other: Sugar Sweetened Solid Treatment; Other: Sugar Sweetened Beverage Treatment	N/A

Detailed Description

Dose: Participants are to consume 1 unit per day of the study product.

Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: The Diet Composition and Energy Balance Pilot Study
• Actual Study Start Date: Jul 21, 2017
• Actual Primary Completion Date: Jun 21, 2018
• Actual Study Completion Date: Jun 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sugar Sweetened Solid Treatment A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.	Other: Sugar Sweetened Solid Treatment; Consume Sugar Sweetened Solid Treatment (product) daily.
Active Comparator: Sugar Sweetened Beverage Treatment 20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.	Other: Sugar Sweetened Beverage Treatment; Consume Sugar Sweetened Beverage Treatment (product) daily.; Other Names: SSB Treatment

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Body Weight [1 month]

   Change from baseline in body weight at 1 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI 20 - 40

Exclusion Criteria:

• Diabetes (Type 1 or 2)

• Prediabetes

• Active cancer

• Serious digestive disorders

• Other conditions that affect metabolism or body weight

• Uncontrolled Thyroid disorder (controlled = 6 months of medication)

• Unable to consume study foods

• Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)

• Pregnancy

• Intentions of becoming pregnant in the next 2 months

• Women who have undergone partial hysterectomy with intact ovary function

• Current or past alcohol or drug abuse problem

• Allergy or intolerance to study product ingredients.

• Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol

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
• Corby K. Martin
• Owen T. Carmichael

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Mar 8, 2018
• Study Protocol - Mar 8, 2018

More Information

Publications

None provided.

• Responsible Party: John Apolzan, Assistant Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT03190993
• Other Study ID Numbers: 6218
• First Posted: Jun 19, 2017
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Sugar Sweetened Solid Treatment	Sugar Sweetened Beverage Treatment
Arm/Group Description	A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sugar Sweetened Solid Treatment	Sugar Sweetened Beverage Treatment	Total
Arm/Group Description	A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	36	39	37
Sex: Female, Male (Count of Participants)
Female	3 30%	6 60%	9 45%
Male	7 70%	4 40%	11 55%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 10%	1 10%	2 10%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 30%	1 10%	4 20%
White	6 60%	8 80%	14 70%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Body Weight
Description	Change from baseline in body weight at 1 month
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Sweetened Solid Treatment	Sugar Sweetened Beverage Treatment
Arm/Group Description	A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.
Measure Participants	10	10
Mean (Standard Error) [kg]	-0.325 (0.307)	0.230 (0.307)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Sweetened Solid Treatment, Sugar Sweetened Beverage Treatment
	Comments
	Type of Statistical Test	Other
	Comments	Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).
Statistical Test of Hypothesis	p-Value	=0.22
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.43
	Estimation Comments

Adverse Events

Time Frame	4 weeks.
Arm/Group Title	Sugar Sweetened Solid Treatment		Sugar Sweetened Beverage Treatment
Arm/Group Description	A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.		20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.
All Cause Mortality
	Sugar Sweetened Solid Treatment		Sugar Sweetened Beverage Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Sugar Sweetened Solid Treatment		Sugar Sweetened Beverage Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Sugar Sweetened Solid Treatment		Sugar Sweetened Beverage Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

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.