Weight LossPOINTSNCT04145466
The Personalized Nutrition Study
A study testing High-fat diet and High-carbohydrate diet in people with Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- High-fat diet and High-carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70806
About this study
Official title: 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.
Read the 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
- Conditions
- Weight Loss
- Being tested
- High-fat diet, High-carbohydrate diet
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat dietBehavioural
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 dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Fat responders (1) | Experimental | receiving high-fat diet Receives: Behavioral: High-fat diet |
| Carbohydrate responders (1) | Experimental | receiving high-fat diet Receives: Behavioral: High-fat diet |
| Fat responders (2) | Experimental | receiving high-carbohydrate diet Receives: Behavioral: High-carbohydrate diet |
| Carbohydrate responders (2) | Experimental | receiving high-carbohydrate diet Receives: Behavioral: High-carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight (kg) at 12 weeks minus weight at baseline (kg)
Measured: Baseline to 12 weeks
Percent Weight Change
Weight change (kg) / weight at baseline (kg) * 100
Measured: Baseline to 12 weeks
Secondary outcomes (6)
Change in Waist Circumference
Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm)
Measured: Baseline to 12 weeks
Change in Food Cravings
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. Responses from all 33 items are then averaged to produce a total score (range 1-5). Lower total scores indicate a low frequency of cravings across several food groups including high fat foods, sweets, carbohydrates, fast food fats, and fruits and vegetables while higher total scores indicate a high frequency of cravings across these food groups.
Change in food cravings is calculated as FCI total score at 12 weeks minus FCI total score at baseline.
Measured: Baseline to 12 weeks
Change in Fat Preference Index
Preference for high- versus low-fat foods is measured with the 74-item Food Preference Questionnaire (FPQ). Individual items in the FPQ measure the preference for either a high fat food or a low fat food on a 9-point Likert scale with the following anchors: 1 = dislike extremely; 5 = neutral, neither like nor dislike; 9 = like extremely.
The fat preference index (range: 1/9 - 9) is then 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.
Change in Fat Preference Index is calculated as Fat Preference Index at 12 weeks minus Fat Preference Index at baseline.
Measured: Baseline to 12 weeks
Change in Disinhibition
Score on the Disinhibition subscale (16-items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Disinhibition score (range: 1-16) is calculated as a sum score of all items within that subscale such that low scores indicate more inhibition while higher scores indicate more disinhibition
Change in Disinhibition is calculated as the score on the Disinhibition subscale at 12 weeks minus the score on the Disinhibition subscale at baseline.
Measured: Baseline to 12 weeks
Change in Hunger
Score on the Hunger subscale (14 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Hunger score (range: 1-14) is calculated as a sum score of all items within that subscale such that low scores indicate a lower tendency to be hungry while higher scores indicate a greater tendency to be hungry.
Change in Hunger is calculated as the score on the Hunger subscale at 12 weeks minus the score on the Hunger subscale at baseline.
Measured: Baseline to 12 weeks
Change in Cognitive Restraint
Score on the Cognitive Restraint subscale (21 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Cognitive Restraint score (range: 1-21) is calculated as a sum score of all items within that subscale such that low scores indicate less cognitive restraint while higher scores indicate greater cognitive restraint.
Change in Cognitive Restraint is calculated as the score on the Cognitive Restraint subscale at 12 weeks minus the score on the Cognitive Restraint subscale at baseline
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start27 Feb 2020
- Primary completion21 Dec 2021
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145466
- Sponsor's protocol ID
- PBRC 2019-043
- Acronym
- POINTS
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2019
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.
Publications
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.
PubMed 37813841
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Personalized Nutrition Study: Evaluation of a Genetically-informed Weight Loss Approach
- ClinicalTrials.gov ID
- NCT04145466
- Acronym / sponsor ID
- POINTS / PBRC 2019-043
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fat responders (1) | Experimental | Behavioral: High-fat dietreceiving high-fat diet |
| Carbohydrate responders (1) | Experimental | Behavioral: High-fat dietreceiving high-fat diet |
| Fat responders (2) | Experimental | Behavioral: High-carbohydrate dietreceiving high-carbohydrate diet |
| Carbohydrate responders (2) | Experimental | Behavioral: High-carbohydrate dietreceiving high-carbohydrate diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat dietThe 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 | Behavioural | Carbohydrate responders (1), Fat responders (1) |
| High-carbohydrate dietThe 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 | Behavioural | Carbohydrate responders (2), Fat responders (2) |
Primary outcome
Weight Change
Time frame: Baseline to 12 weeks
Weight (kg) at 12 weeks minus weight at baseline (kg)
Percent Weight Change
Time frame: Baseline to 12 weeks
Weight change (kg) / weight at baseline (kg) * 100
6 secondary outcomes
Change in Waist Circumference
Time frame: Baseline to 12 weeks
Change in Food Cravings
Time frame: Baseline to 12 weeks
Change in Fat Preference Index
Time frame: Baseline to 12 weeks
Change in Disinhibition
Time frame: Baseline to 12 weeks
Change in Hunger
Time frame: Baseline to 12 weeks
Change in Cognitive Restraint
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37813841Hochsmann 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.
- Individual participant dataSharing planned: No. Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat diet and High-carbohydrate diet in people with Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.