PREMIER: PREvention of Metabolic Illness Through prEcision nutRition

Obesity Clinical Trial

— PREMIER  

Official title:

PREMIER: PREvention of Metabolic Illness Through prEcision nutRition

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04148482
• Other study ID #: 2019P002638
• Secondary ID: P30DK040561
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: March 28, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: March 28, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massacusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston Area Diabetes Endocrinology Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NORCH (Nutrition Obesity Research Center at Harvard)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Measurement of blood glucose at regular intervals.	Day 1
Primary	High-fat meal preference	Number of participants with preference for a high-fat meal.	Day 1
Primary	Hunger perception before and after test meals consumption using visual analogue scales	Record of hunger perception before and after test meals using visual analogue scales. Participants will provide ratings raging from 0 to 100 based on six questions commonly used in visual analogue scales including: "How hungry do you feel?" (0=not at all hungry / 100=as hungry as I've ever felt); "How full do you feel?" (100=not at all full / 0=as full as I have ever felt); "How strong is your desire to eat?" (0=very weak / 100=very strong); "How much do you think you could eat now?" (0=nothing at all / 100=a large amount); "Urge to eat" (0=no urge to eat / 100=strong, want to eat now, waiting is very uncomfortable); "Preoccupation with thoughts of food" (0=no thoughts of food / 100=very preoccupied difficult to concentrate on other things). The minimum and maximum values range from 0 to 100, with higher numbers indicating higher hunger perception.	Day 1
Secondary	Metabolomics by mass spectrometry analysis	Investigators will perform metabolomic profiling of plasma samples at regular intervals by using both targeted and untargeted approaches on an existing platform that measures ~10000 metabolites (both polar and non-polar); they will compare their relative concentrations by genotype at selected loci before and after the interventions.	Day 1
Secondary	Incretin levels by immunoassay kits	Measurement of blood Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide (GIP) concentrations at regular intervals	Day 1
Secondary	Appetite satiety hormones levels by immunoassay kits	Measurement of blood Ghrelin, Leptin, Peptide YY (PYY), and Cholecystokinin (CCK) at regular intervals.	Day 1