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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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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.
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.
Carbohydrate responders and fat responders will be randomized to one of the following two diets:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat responders (1) | Experimental | receiving high-fat diet |
|
| Carbohydrate responders (1) | Experimental | receiving high-fat diet |
|
| Fat responders (2) | Experimental | receiving high-carbohydrate diet |
|
| Carbohydrate responders (2) | Experimental | receiving high-carbohydrate diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist Circumference | Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm) | 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. |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37813841 | Derived | 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. |
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Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fat Responders (1) | receiving high-fat diet 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 |
| FG001 | Carbohydrate Responders (1) | receiving high-fat diet 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 |
| FG002 | Fat Responders (2) | receiving high-carbohydrate diet 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 |
| FG003 | Carbohydrate Responders (2) | receiving high-carbohydrate diet 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Includes participants that completed the study and were included in the analysis. Of the 129 participants that completed the study, 7 participants were incorrectly genotyped and were not included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fat Responders (1) | receiving high-fat diet 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | Weight (kg) at 12 weeks minus weight at baseline (kg) | Posted | Mean | Standard Deviation | kg | Baseline to 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fat Responders (1) | receiving high-fat diet 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized | Gastrointestinal disorders | Systematic Assessment | Admitted to hospital 3/18/2021 to drain abscess on colon. History of diverticulitis. D/C'd on 03/21/2021 and back home. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphodema | Blood and lymphatic system disorders | Systematic Assessment | Lymphodema diagnosed after a surgery to repair a broken leg. The surgery was in Dec. 2020. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christoph Hoechsmann | Department of Health and Sport Sciences, TUM School of Medicine and Health, Technical University of Munich | +49 (89) 289 - 24492 | christoph.hoechsmann@tum.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Oct 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2021 | Oct 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059305 | Diet, High-Fat |
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized controlled parallel arm trial with 4 groups over 12 weeks
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.
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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.
|
| 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 |
|
| 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. | 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. | 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. | 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 | Baseline to 12 weeks |
| BG001 | Carbohydrate Responders (1) | receiving high-fat diet 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 |
| BG002 | Fat Responders (2) | receiving high-carbohydrate diet 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 |
| BG003 | Carbohydrate Responders (2) | receiving high-carbohydrate diet 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG002 | Fat Responders (2) | receiving high-carbohydrate diet 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 |
| OG003 | Carbohydrate Responders (2) | receiving high-carbohydrate diet 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 |
|
|
| Primary | Percent Weight Change | Weight change (kg) / weight at baseline (kg) * 100 | Posted | Mean | Standard Deviation | percent | Baseline to 12 weeks |
|
|
|
| Secondary | Change in Waist Circumference | Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm) | Posted | Mean | Standard Deviation | cm | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| 0 |
| 46 |
| EG001 | Carbohydrate Responders (1) | receiving high-fat diet 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 | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Fat Responders (2) | receiving high-carbohydrate diet 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 | 0 | 43 | 1 | 43 | 2 | 43 |
| EG003 | Carbohydrate Responders (2) | receiving high-carbohydrate diet 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 | 0 | 18 | 0 | 18 | 0 | 18 |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Diagnosed with RSV and was hospitalized due to difficulty breathing. |
|
|
| Lipedema | Cardiac disorders | Systematic Assessment | Lipedema and fluid retention. Prior ankle surgery cause of this (before POINTS participation). Weight fluctuating frequently. |
|
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| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D000073600 | Diet, High-Protein |