The DEB Pilot Study

Not Applicable

Completed

• Conditions: Obesity; Nutritional Physiological Phenomena
• Interventions: Other: Sugar Sweetened Solid Treatment; Other: Sugar Sweetened Beverage Treatment

• Registration Number: NCT03190993
• Lead Sponsor: Pennington Biomedical Research Center

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.

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 Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-07-21
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Results First Submitted: 2019-08-26
• Results First Submitted QC: 2020-05-04
• Results First Posted: 2020-05-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Sweetened Solid Treatment	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.
Sugar Sweetened Beverage Treatment	Sugar Sweetened Beverage Treatment	20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	1 month	Change from baseline in body weight at 1 month

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States