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Dietary Intervention for Metabolic Diseases (PREMIER Trial)

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21-65 years of age

Healthy (free of diagnosed diseases listed in the exclusion criteria)

Must not have

History of cirrhosis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal (ULN)

Have an ongoing inflammatory disease i.e. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Summary

This trial will help to better understand the biological, environmental, and social factors that influence how people interact and respond to specific foods.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a dietary intervention study focusing on normal eating patterns without introducing drugs or medical procedures, significant side effects are not anticipated beyond possible minor digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have an ongoing inflammatory disease like rheumatoid arthritis.

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I am currently diagnosed with severe depression.

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I have had a heart attack or stroke.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose

High-fat meal preference

Hunger perception before and after test meals consumption using visual analogue scales

Secondary study objectives

Immunoassay method

Incretin levels by immunoassay kits

Metabolomics by mass spectrometry analysis

Trial Design

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.

0 / 9Eligibility criteria met