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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
Awards & highlights
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 belowSelect...
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:Select...
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
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,691 Total Patients Enrolled
NORCH (Nutrition Obesity Research Center at Harvard)UNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,409 Previous Clinical Trials
4,324,879 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very overweight or underweight based on your height.I am between 21 and 65 years old.I have a history of cirrhosis or my liver enzymes are more than three times the normal limit.I am either male or female.Your body mass index (BMI) is between 18.5 and 30.0 kg/m2.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 healthy and do not have any of the diseases listed as exclusions.I am taking or plan to take medication that can affect blood sugar levels.You are vegan, have an eating disorder, or unwilling to eat the foods involved in the study.I have diabetes (type I or II) or am on medication for type II diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Genotype of interest group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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