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NCT Number: NCT04148482

PREMIER: PREvention of Metabolic Illness Through prEcision nutRition

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.

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Key information

Conditions

Obesity Behavior Behavior, Animal Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Diet Habit Endocrine System Diseases Feeding Behavior Food Preferences Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Disease Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female.
  • 21-65 years of age.
  • Body mass index (BMI) between 18.5 and 30.0 kg/m2.
  • Healthy (free of diagnosed diseases listed in the exclusion criteria).
  • Willing to comply with the study intervention.
  • Able to provide informed consent

Exclusion criteria

  • 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.

Treatment and study plan

Dietary Intervention

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.

Primary outcomes

  1. Glucose at Times 30min, 60min, 120min, 180min

    Time frame: Day 1

    Measurement of blood glucose at regular intervals.

  2. High-fat Meal Preference

    Time frame: Day 1

    Number of participants with preference for a high-fat meal.

Secondary outcomes

  1. Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline)

    Time frame: Day 1

    Investigators will perform metabolomic profiling of plasma samples at regular intervals by using both targeted and untargeted approaches on an existing platform that measures ~10,000 metabolites (both polar and non-polar); they will compare their relative concentrations (fold change) by genotype at selected loci before and after the interventions. Metabolomics will be performed using LC-MS techniques in the Clish Laboratory of the Broad Institute of MIT and Harvard (Cambridge, MA). Fold-change in metabolite values (from 0->120, 0->240, and 240->360 minutes) will be statistically analyzed to identify distinct patterns of metabolite change in response to mixed meals by genotype. Examples of metabolomic fold-change readouts are provided below, by genotype - limited examples are provided as fold-change reporting for ~10,000 metabolites, identified and unidentified, at 3 time points would be impracticable.

Other outcomes

  1. Previously Proposed Outcomes: Hunger Perception, Incretin Levels by Immunoassay Kit, Satiety Hormones

    Time frame: baseline, 120min, 240min, 360min

    Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston Area Diabetes Endocrinology Research Center
  • NORCH (Nutrition Obesity Research Center at Harvard)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PREMIER

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2019
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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