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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
PREMIER Trial 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.Check my eligibility
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.See study design
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.
PREMIER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
Select...
I am healthy and do not have any of the diseases listed as exclusions.
PREMIER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose
High-fat meal preference
Hunger perception before and after test meals consumption using visual analogue scales
Secondary outcome measures
Immunoassay method
Incretin levels by immunoassay kits
Metabolomics by mass spectrometry analysis
PREMIER 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
2,925 Previous Clinical Trials
13,197,874 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
2,350 Previous Clinical Trials
4,314,772 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental process accessible to individuals aged 85 and under?
"This medical trial requires participants to be between 21 and 65 years old. Alternatively, there are 253 clinical trials available for those younger than 18 while 1030 studies exist specifically tailored to seniors over the age of 65."
Answered by AI
Who is eligible to partake in this research?
"This clinical trial is seeking 30 candidates who possess obesity and are of an age within the range of 21 to 65 years."
Answered by AI
Are there opportunities to join this clinical investigation?
"Clinicaltrials.gov indicates this clinical trial is not currently searching for recruits, having first been posted on September 16th 2021 and last edited May 25th 2022. However, there are a plethora of other medical studies which have openings right now - 1511 to be precise!"
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Massacusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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