Dietary Intervention for Metabolic Diseases (PREMIER Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

The PREMIER study is for men and women aged 21-65 with a BMI of 18.5 to 30, who are generally healthy and willing to follow the dietary intervention. It's not for those with heart issues, depression, certain diseases like diabetes or inflammatory conditions, or anyone on medications affecting blood sugar.

Inclusion Criteria

I am between 21 and 65 years old.

I am healthy and do not have any of the diseases listed as exclusions.

Exclusion Criteria

I have a history of cirrhosis or my liver enzymes are more than three times the normal limit.

I have an ongoing inflammatory disease like rheumatoid arthritis.

I am currently diagnosed with severe depression.

I have had a heart attack or stroke.

I have had cancer, other than skin cancer, in the last 3 years.

I am taking or plan to take medication that can affect blood sugar levels.

I have diabetes (type I or II) or am on medication for type II diabetes.

Treatment Details

This trial tests how different people respond to specific foods based on their genetic makeup. Participants will eat a standardized meal so researchers can measure changes in blood glucose and other biomarkers related to food preferences and metabolic health.

2Treatment groups

Active Control

Placebo Group

Group I: Genotype of interest groupActive Control1 Intervention

Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.

Group II: ControlPlacebo Group1 Intervention

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.