- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145466
The Personalized Nutrition Study (POINTS)
The Personalized Nutrition Study: Evaluation of a Genetically-informed Weight Loss Approach
Study Overview
Status
Conditions
Intervention / Treatment
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:
- A high-quality high-carbohydrate diet that is rich in whole-grain foods, or
- A high-quality high-fat diet that is rich in unsaturated fats and oils
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70806
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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