PREMIER: PREvention of Metabolic Illness Through prEcision nutRition

NCT ID: NCT04148482

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2024-09-19

Brief Summary

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.

Conditions

Obesity; Type 2 Diabetes; Metabolic Syndrome; Diet Habit; Nutritional and Metabolic Disease; Food Preferences

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Genotype of interest group

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

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: OTHER

To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal.

Control

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.

Group Type: PLACEBO_COMPARATOR

Dietary intervention

Intervention Type: OTHER

To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal.

Interventions

Dietary intervention

To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female.
• 21-65 years of age.
• Body mass index (BMI) between 18.5 and 30.0 kg/m2.

Exclusion Criteria

• Willing to comply with the study intervention.
• Able to provide informed consent

• Refuse or are unable to give informed consent to participate in the study.
• Have type I or type II diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of >126 mg/dL based on fingertip glucose measurements will be excluded.
• Are obese (BMI>30.0kg/m2) or underweight (BMI<18.5kg/m2).
• Have had a heart attack (myocardial infarction) or stroke
• Have had cancer in the last 3 years, excluding skin cancer.
• Have an ongoing inflammatory disease i.e. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
• History of cirrhosis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal (ULN).
• Are currently suffering from acute clinically diagnosed depression.
• Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids or fluoroquinolones.
• Are unable to fast from 9pm the night before the clinic visit until 9am on the clinic day
• Are pregnant or breastfeeding.
• Are participating in another clinical study.
• Are vegan, suffering from an eating disorder or unwilling to eat foods that are part of the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

NORCH (Nutrition Obesity Research Center at Harvard)

UNKNOWN

Sponsor Role: collaborator

Boston Area Diabetes Endocrinology Research Center

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara Cromer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massacusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P30DK040561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P002638

Identifier Type: -

Identifier Source: org_study_id