N/A
N=145
The Personalized Nutrition Study
Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT04145466 ↗Enrolled (actual)
145
Serious AEs
1.6%
Results posted
Jan 2025
Primary outcome: Primary: Weight Change — -5.5; -4.1; -5.3; -5.1 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-fat diet (Behavioral); High-carbohydrate diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
-5.5; -4.1; -5.3; -5.1 | — |
| PRIMARY Percent Weight Change |
-5.9; -4.8; -5.7; -5.7 | — |
| SECONDARY Change in Waist Circumference |
-5.0; -4.2; -4.4; -4.4 | — |
| SECONDARY Change in Food Cravings |
-0.3; -0.5; -0.3; 0.0 | — |
| SECONDARY Change in Fat Preference Index |
0.0; 0.0; 0.0; -0.2 | — |
| SECONDARY Change in Disinhibition |
-0.3; 0.0; 0.2; 0.7 | — |
| SECONDARY Change in Hunger |
-0.9; -0.1; -1.3; 0.8 | — |
| SECONDARY Change in Cognitive Restraint |
3.5; 4.6; 2.7; 3.4 | — |
Summary
A person's genetic code is believed to affect how much weight he/she will lose during diets that vary in carbohydrate and dietary fat content. 'Carbohydrate responders' are hypothesized to lose more weight on diets that are high in carbohydrates, as compared to high in fats. 'Fat responders' are hypothesized to lose more weight on diets that are high in dietary fat, as compared to high in carbohydrates. The purpose of the proposed study is to test these hypotheses in a randomized controlled trial.
Eligibility Criteria
Inclusion Criteria
- BMI ≥ 27.0 kg/m2 to < 47.5 kg/m2
- Completed genealogy test and access to the raw data
- Fat responder or Carbohydrate responder, as determined by genetic risk score
It is estimated that approximately 1/3 of people are fat responders, 1/3 are carbohydrate responders, and 1/3 are neither or will respond to either diet. Only carbohydrate and fat responders are eligible.
Exclusion Criteria
- Current smoker or has smoked in the previous year
- For females, pregnant or planned pregnancy during the study duration, or breast-feeding, based on self-report
- Conditions, diseases, or medications that affect body weight or metabolism (e.g., certain antipsychotic medications; type 2 diabetes mellitus; heart failure; cancer, excluding certain melanomas; etc.)
- Has gained or lost more than 10 pounds in the last 3 months
- Currently diagnosed with an eating disorder, major depression, or other condition that, in the judgment of the investigators, could affect the risk to the participant or study completion
Data sourced from ClinicalTrials.gov (NCT04145466). 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.