The Diet Composition and Energy Balance Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Body Weight
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Sugar Sweetened Solid Treatment (Other)
Sugar Sweetened Beverage Treatment
20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.
Intervention: Sugar Sweetened Beverage Treatment (Other)
Outcomes
Primary Outcomes
Change From Baseline in Body Weight
Time Frame: 1 month
Change from baseline in body weight at 1 month
Secondary Outcomes
No secondary outcomes reported
Investigators
John Apolzan
Assistant Professor
Pennington Biomedical Research Center