N/A
N=20
The DEB Pilot Study
Nutritional Physiological Phenomena · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03190993 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change From Baseline in Body Weight — -0.325; 0.230 kg — p==0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sugar Sweetened Solid Treatment (Other); Sugar Sweetened Beverage Treatment (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight |
-0.325; 0.230 | =0.22 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03190993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.