Clinical trial NCT04148482: PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Official title: PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Metabolic Syndrome
Diet Habit
Nutritional and Metabolic Disease
Food Preferences
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: NORCH (Nutrition Obesity Research Center at Harvard)
name: Boston Area Diabetes Endocrinology Research Center
First posted: 2019-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a recall-by-genotype study
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glucose
timeFrame: Day 1
measure: High-fat Meal Preference
timeFrame: Day 1
Secondary outcomes:
measure: Metabolomics by Mass Spectrometry Analysis
timeFrame: Day 1
measure: Incretin Levels by Immunoassay Kits
timeFrame: Day 1
measure: Appetite Satiety Hormones Levels by Immunoassay Kits
timeFrame: Day 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massacusetts General Hospital
state: Massachusetts
Study officials:
References: