NCT04148482Completed
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Source: ClinicalTrials.gov · Last updated 23 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 18 Oct 2019
- Start date
- 17 Jun 2021
- Primary completion date
- 19 Sept 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04148482
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 17 Jun 2021 to the primary completion date, 19 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids or fluoroquinolones.
Other illness
- Have had a heart attack (myocardial infarction) or stroke
- Have had cancer in the last 3 years, excluding skin cancer.
- Have an ongoing inflammatory disease i.e. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
- Are vegan, suffering from an eating disorder or unwilling to eat foods that are part of the study.
Lab values
- Have type I or type II diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of \>126 mg/dL based on fingertip glucose measurements will be excluded.
- History of cirrhosis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal (ULN).
Other
- Refuse or are unable to give informed consent to participate in the study.
- Are obese (BMI\>30.0kg/m2) or underweight (BMI\<18.5kg/m2).
- Are currently suffering from acute clinically diagnosed depression.
- Are unable to fast from 9pm the night before the clinic visit until 9am on the clinic day
- Are pregnant or breastfeeding.
- Are participating in another clinical study.
Who the study is looking for
- Male or female.
- 21-65 years of age.
- Body mass index (BMI) between 18.5 and 30.0 kg/m2.
- Healthy (free of diagnosed diseases listed in the exclusion criteria).
- Willing to comply with the study intervention.
- Able to provide informed consent
Age in the registry: 21 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massacusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.