NCT03190993CompletedNot Applicable
The Diet Composition and Energy Balance Pilot Study
Pennington Biomedical Research Center2 sites in 1 country20 target enrollmentStarted: July 21, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- 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
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
Study Sites (2)
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