The Personalized Nutrition Study (POINTS)

February 15, 2024 updated by: Corby K. Martin, Pennington Biomedical Research Center

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

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 Overview

Status

Completed

Conditions

Detailed Description

Obesity and its comorbidities are major public health challenges. To combat the obesity pandemic, many weight-loss strategies have been studied, often emphasizing either high carbohydrate (low fat) diets or high fat (low carbohydrate) diets. Mean weight loss differences between high-carbohydrate and high-fat diets that induce equal caloric deficits have been reported to be small; however, the individual weight loss response varies substantially within diet groups, suggesting that different individuals react differently to high-carbohydrate or high-fat diets. This assumption is supported by retrospective data showing that participants with carbohydrate-responsive polymorphisms lost 2-3 times more weight when assigned to a high-carbohydrate diet compared to a high-fat diet, and vice versa for those with dietary fat-responsive polymorphisms. Conversely, a recent randomized clinical trial aimed to determine the effect of a healthy high-fat diet (high in unsaturated fats) vs. a healthy high-carbohydrate diet (high in whole-grain foods) on 12-month weight change but did not find significant differences between the two groups and failed to find the hypothesized association between genotype patterns and weight loss induced by diets that varied in fat and carbohydrate content. However, an important caveat of their approach is that the single nucleotide polymorphisms selected by the investigators had not been previously associated with obesity or with dietary responses, which may explain their lack of predictive value in identifying differences in inter-individual responses. In addition, the fat composition of the diets was relatively high in both high- and low-fat groups. The inconsistent findings in the literature indicate a need for further research to determine if genetic factors affect weight loss when exposed to diets that vary in carbohydrates and dietary fats.

The purpose of this randomized controlled parallel arm trial is to test the following hypotheses.

Hypothesis 1 will test if participants assigned to the diet that corresponds to their genotype lose more weight than those assigned to a diet inconsistent with their genotype.

Hypothesis 2 will analyze the fat responders and carbohydrate responders separately.

  • Hypothesis 2a: Fat responders will lose more weight on the high-fat diet vs. the high-carbohydrate diet.
  • Hypothesis 2b: Carbohydrate responders will lose more weight on the high-carbohydrate diet vs. the high-fat diet.

Carbohydrate responders and fat responders will be randomized to one of the following two diets:

  1. A high-quality high-carbohydrate diet that is rich in whole-grain foods, or
  2. A high-quality high-fat diet that is rich in unsaturated fats and oils

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fat responders (1)
receiving high-fat diet

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

Experimental: Carbohydrate responders (1)
receiving high-fat diet

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

Experimental: Fat responders (2)
receiving high-carbohydrate diet

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

Experimental: Carbohydrate responders (2)
receiving high-carbohydrate diet

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change
Time Frame: Baseline to 12 weeks
Weight (kg) at 12 weeks minus weight at baseline (kg)
Baseline to 12 weeks
Percent Weight Change
Time Frame: Baseline to 12 weeks
Weight change (kg) / weight at baseline (kg) * 100
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Waist Circumference
Time Frame: Baseline to 12 weeks
Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm)
Baseline to 12 weeks
Change in Food Cravings
Time Frame: Baseline to 12 weeks

Food cravings are assessed via the total score of the 33-item Food Craving Inventory (FCI). The FCI is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always = 5.

Change in food cravings is calculated as FCI total score at 12 weeks minus FCI total score at baseline.

Baseline to 12 weeks
Change in Fat Preference Index
Time Frame: Baseline to 12 weeks

Preference for high- versus low-fat foods is measured with the Food Preference Questionnaire (FPQ) and a fat preference index is calculated as the mean rating for high-fat foods divided by the mean rating for low-fat foods. Values greater than 1.0 reflect a higher fat preference, and values less than 1.0 reflect a lower fat preference. Items in the FPQ are rated on a 9-point Likert scale with the following anchors: 1 = dislike extremely; 5 = neutral, neither like nor dislike; 9 = like extremely.

Change in Fat Preference Index is calculated as Fat Preference Index at 12 weeks minus Fat Preference Index at baseline.

Baseline to 12 weeks
Change in Disinhibition
Time Frame: Baseline to 12 weeks

Score on the Disinhibition subscale of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true' or 'false'.

Change in Disinhibition is calculated as the score in the Disinhibition subscale at 12 weeks minus the score in the Disinhibition subscale at baseline.

Baseline to 12 weeks
Change in Hunger
Time Frame: Baseline to 12 weeks

Score on the Hunger subscale of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true' or 'false'.

Change in Hunger is calculated as the score in the Hunger subscale at 12 weeks minus the score in the Hunger subscale at baseline.

Baseline to 12 weeks
Change in Cognitive Restraint
Time Frame: Baseline to 12 weeks

Score on the Cognitive Restraint subscale of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true' or 'false'.

Change in Cognitive Restraint is calculated as the score in the Cognitive Restraint subscale at 12 weeks minus the score in the Cognitive Restraint subscale at baseline

Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2019-043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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