The Personalized Nutrition Study

NCT04145466 | Completed Results

• 1 other identifier: PBRC 2019-043
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

• Weight Change

  Weight (kg) at 12 weeks minus weight at baseline (kg)

  Baseline to 12 weeks

• Percent Weight Change

  Weight change (kg) / weight at baseline (kg) \* 100

  Baseline to 12 weeks

Secondary Outcomes (6)

• Change in Waist Circumference

  Baseline to 12 weeks

• Change in Food Cravings

  Baseline to 12 weeks

• Change in Fat Preference Index

  Baseline to 12 weeks

• Change in Disinhibition

  Baseline to 12 weeks

• Change in Hunger

  Baseline to 12 weeks

Study Arms (4)

Fat responders (1)

EXPERIMENTAL

receiving high-fat diet

Behavioral: High-fat diet

Carbohydrate responders (1)

EXPERIMENTAL

receiving high-fat diet

Behavioral: High-fat diet

Fat responders (2)

EXPERIMENTAL

receiving high-carbohydrate diet

Behavioral: High-carbohydrate diet

Carbohydrate responders (2)

EXPERIMENTAL

receiving high-carbohydrate diet

Behavioral: High-carbohydrate diet

Interventions

High-fat diet BEHAVIORAL

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

Carbohydrate responders (1); Fat responders (1)

High-carbohydrate diet BEHAVIORAL

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

Carbohydrate responders (2); Fat responders (2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• WW International Inc: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

Location

Related Publications (1)

• Hochsmann C, Yang S, Ordovas JM, Dorling JL, Champagne CM, Apolzan JW, Greenway FL, Cardel MI, Foster GD, Martin CK. The Personalized Nutrition Study (POINTS): evaluation of a genetically informed weight loss approach, a Randomized Clinical Trial. Nat Commun. 2023 Oct 9;14(1):6321. doi: 10.1038/s41467-023-41969-1.

  PMID: 37813841 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Diet, High-Fat; Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein

Results Point of Contact

• Title: Christoph Hoechsmann
• Organization: Department of Health and Sport Sciences, TUM School of Medicine and Health, Technical University of Munich

christoph.hoechsmann@tum.de

+49 (89) 289 - 24492

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to diet assignment and genotype pattern. Interventionists will be blind to genotype pattern, but not diet type. To enhance external validity, participants will be told if they are carbohydrate or fat responders.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled parallel arm trial with 4 groups over 12 weeks 1. Fat responders receiving a high-fat diet (n=52) 2. Fat responders receiving a high-carbohydrate diet (n=52) 3. Carbohydrate responders receiving a high-fat diet (n=25) 4. Carbohydrate responders receiving a high-carbohydrate diet (n=25) The total number per group is an estimate. We will not close cells to enroll this exact number per group, and the total number of people enrolled will not exceed 154.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: February 27, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 30, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)