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PREMIER: PREvention of Metabolic Illness Through prEcision nutRition (PREMIER)

Primary Purpose

Obesity, Type 2 Diabetes, Metabolic Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massacusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Genotype of interest group

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Glucose
Measurement of blood glucose at regular intervals.
High-fat meal preference
Number of participants with preference for a high-fat meal.
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.

Secondary Outcome Measures

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.
Incretin levels by immunoassay kits
Measurement of blood Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide (GIP) concentrations at regular intervals
Appetite satiety hormones levels by immunoassay kits
Measurement of blood Ghrelin, Leptin, Peptide YY (PYY), and Cholecystokinin (CCK) at regular intervals.

Full Information

First Posted
October 18, 2019
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NORCH (Nutrition Obesity Research Center at Harvard), Boston Area Diabetes Endocrinology Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04148482
Brief Title
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Acronym
PREMIER
Official Title
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NORCH (Nutrition Obesity Research Center at Harvard), Boston Area Diabetes Endocrinology Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes, Metabolic Syndrome, Diet Habit, Nutritional and Metabolic Disease, Food Preferences

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This is a recall-by-genotype study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genotype of interest group
Arm Type
Active Comparator
Arm Description
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
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 Outcome Measure Information:
Title
Glucose
Description
Measurement of blood glucose at regular intervals.
Time Frame
Day 1
Title
High-fat meal preference
Description
Number of participants with preference for a high-fat meal.
Time Frame
Day 1
Title
Hunger perception before and after test meals consumption using visual analogue scales
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Metabolomics by mass spectrometry analysis
Description
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.
Time Frame
Day 1
Title
Incretin levels by immunoassay kits
Description
Measurement of blood Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide (GIP) concentrations at regular intervals
Time Frame
Day 1
Title
Appetite satiety hormones levels by immunoassay kits
Description
Measurement of blood Ghrelin, Leptin, Peptide YY (PYY), and Cholecystokinin (CCK) at regular intervals.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Massacusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Our research team will provide a personalized report containing individual's glycemic responses and potentially other biomarker responses to meals consumed by the end of the study.
IPD Sharing Time Frame
6-12 months after finishing the study intervention

Learn more about this trial

PREMIER: PREvention of Metabolic Illness Through prEcision nutRition

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