24 Participants Needed

Dietary Intervention for Metabolic Diseases

(PREMIER Trial)

JM
Overseen ByJordi Merino, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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 either male or female.
Your body mass index (BMI) is between 18.5 and 30.0 kg/m2.
See 3 more

Exclusion Criteria

You are very overweight or underweight based on your height.
Are participating in another clinical study
I have a history of cirrhosis or my liver enzymes are more than three times the normal limit.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a standardized and an election meal to measure the response of blood glucose and other biomarkers

1 day
1 full-day clinic visit

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PREMIER
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Genotype of interest groupActive Control1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

NORCH (Nutrition Obesity Research Center at Harvard)

Collaborator

Trials
2
Recruited
60+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Boston Area Diabetes Endocrinology Research Center

Collaborator

Trials
1
Recruited
30+
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