ObesityPREMIERNCT04148482
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
A study testing Dietary intervention in people with Obesity and Type 2 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massacusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Being tested
- Dietary intervention
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Metabolic Syndrome, Feeding Behavior, Metabolic Diseases, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Genotype of interest group | Active comparator | Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. Receives: Other: Dietary intervention |
| Control | Placebo comparator | 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. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose at Times 30min, 60min, 120min, 180min
Measurement of blood glucose at regular intervals.
Measured: Day 1
High-fat Meal Preference
Number of participants with preference for a high-fat meal.
Measured: Day 1
Secondary outcomes (1)
Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start17 Jun 2021
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- This is a recall-by-genotype study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NORCH (Nutrition Obesity Research Center at Harvard), Boston Area Diabetes Endocrinology Research Center
- Responsible party
- Principal investigator, Sara Cromer, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148482
- Sponsor's protocol ID
- 2019P002638
- Other IDs
- P30DK040561
- Acronym
- PREMIER
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2019
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
- ClinicalTrials.gov ID
- NCT04148482
- Acronym / sponsor ID
- PREMIER / 2019P002638
- Conditions
- Obesity, Type 2 Diabetes, Metabolic Syndrome, Diet Habit, Nutritional and Metabolic Disease, Food Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NORCH (Nutrition Obesity Research Center at Harvard), Boston Area Diabetes Endocrinology Research Center
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a recall-by-genotype study
| Arm | Type | Receives |
|---|---|---|
| Genotype of interest group | Active comparator | Other: Dietary interventionIndividuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit. |
| Control | Placebo comparator | Other: Dietary interventionIndividuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionTo 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. | Other | Control, Genotype of interest group |
Primary outcome
Glucose at Times 30min, 60min, 120min, 180min
Time frame: Day 1
Measurement of blood glucose at regular intervals.
High-fat Meal Preference
Time frame: Day 1
Number of participants with preference for a high-fat meal.
1 secondary outcome
Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Obesity and Type 2 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose at Times 30min, 60min, 120min, 180min (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.