CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
High-fat diet +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04145466
NCT04145466N/ACompleted

The Personalized Nutrition Study: Evaluation of a Genetically-informed Weight Loss Approach

Pennington Biomedical Research Center·interventional·Posted Oct 30, 2019·Updated Jan 30, 2025

In Brief

A clinical study evaluating High-fat diet and High-carbohydrate diet for Weight Loss. Completed, enrolled 145 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Loss
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 30, 2019
Enrollment StartFeb 27, 2020
Primary CompletionDec 21, 2021
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.7 years ago

Interventions

High-fat dietbehavioral

The high-fat diet will consist of \~40% energy from fat and \~45% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed

High-carbohydrate dietbehavioral

The high-carbohydrate diet will consist of \~20% of energy from fat and \~65% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed