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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK040561 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| NORCH (Nutrition Obesity Research Center at Harvard) | UNKNOWN |
| Boston Area Diabetes Endocrinology Research Center | UNKNOWN |
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Dietary intake is a major driving force behind the escalating obesity and type 2 diabetes epidemics. Large, high-quality clinical trials have shown that close adherence to healthy dietary recommendations significantly reduce the incidence of obesity and type 2 diabetes, especially among people at increased risk. However, large inter-individual variability exists in response to dietary interventions. To inform more effective obesity and type 2 diabetes prevention strategies, it is crucial to better understand the biological, environmental, and social factors that influence how people interact and respond to specific foods.
In a recent large-scale genome-wide association study, our research team has identified 96 genomic regions associated with overall variation in dietary intake. This study provided evidence that inherited molecular differences are likely to impact on food intake (i.e., preference for certain foods) and metabolic homeostasis (i.e., glucose regulation). Connecting knowledge about human genetic variants with information from circulating metabolites can be particularly useful in understanding the mechanisms by which some people experience a detrimental response to specific foods.
The specific objective of the PREMIER study is to carry out an interventional dietary study to measure the response of blood glucose and other biomarkers to a standardized meal, and evaluate the extent to which food choices differ among individuals with distinct genetic susceptibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype of interest group | Active Comparator | Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. |
|
| Control | Placebo Comparator | Individuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose at Times 30min, 60min, 120min, 180min | Measurement of blood glucose at regular intervals. | Day 1 |
| High-fat Meal Preference | Number of participants with preference for a high-fat meal. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline) | Investigators will perform metabolomic profiling of plasma samples at regular intervals by using both targeted and untargeted approaches on an existing platform that measures ~10,000 metabolites (both polar and non-polar); they will compare their relative concentrations (fold change) by genotype at selected loci before and after the interventions. Metabolomics will be performed using LC-MS techniques in the Clish Laboratory of the Broad Institute of MIT and Harvard (Cambridge, MA). Fold-change in metabolite values (from 0->120, 0->240, and 240->360 minutes) will be statistically analyzed to identify distinct patterns of metabolite change in response to mixed meals by genotype. Examples of metabolomic fold-change readouts are provided below, by genotype - limited examples are provided as fold-change reporting for ~10,000 metabolites, identified and unidentified, at 3 time points would be impracticable. |
| Measure | Description | Time Frame |
|---|---|---|
| Previously Proposed Outcomes: Hunger Perception, Incretin Levels by Immunoassay Kit, Satiety Hormones | Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected. | baseline, 120min, 240min, 360min |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massacusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Our research team will provide a personalized report containing individual's glycemic responses and potentially other biomarker responses to meals consumed by the end of the study.
6-12 months after finishing the study intervention
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotype of Interest Group | Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
| FG001 | Control | Individuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotype of Interest Group | Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Glucose at Times 30min, 60min, 120min, 180min | Measurement of blood glucose at regular intervals. | Posted | Mean | Standard Deviation | mg/dL | Day 1 |
|
8 hours
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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 | Genotype of Interest Group | Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Cromer | Massachusetts General Hospital | 6177247303 | scromer@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2023 | May 9, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2025 | May 9, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| D005247 | Feeding Behavior |
| D008659 | Metabolic Diseases |
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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This is a recall-by-genotype study
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| Day 1 |
| BG001 | Control | Individuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glucose at time 0 | Mean | Standard Deviation | mg/dL |
|
|
|
| Primary | High-fat Meal Preference | Number of participants with preference for a high-fat meal. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline) | Investigators will perform metabolomic profiling of plasma samples at regular intervals by using both targeted and untargeted approaches on an existing platform that measures ~10,000 metabolites (both polar and non-polar); they will compare their relative concentrations (fold change) by genotype at selected loci before and after the interventions. Metabolomics will be performed using LC-MS techniques in the Clish Laboratory of the Broad Institute of MIT and Harvard (Cambridge, MA). Fold-change in metabolite values (from 0->120, 0->240, and 240->360 minutes) will be statistically analyzed to identify distinct patterns of metabolite change in response to mixed meals by genotype. Examples of metabolomic fold-change readouts are provided below, by genotype - limited examples are provided as fold-change reporting for ~10,000 metabolites, identified and unidentified, at 3 time points would be impracticable. | Posted | Mean | Standard Deviation | fold-change from baseline | Day 1 |
|
|
|
| Other Pre-specified | Previously Proposed Outcomes: Hunger Perception, Incretin Levels by Immunoassay Kit, Satiety Hormones | Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected. | Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected. | Posted | baseline, 120min, 240min, 360min |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Individuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit. Dietary intervention: To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D001522 | Behavior, Animal |
| D001519 | Behavior |