Trial Outcomes & Findings for PREMIER: PREvention of Metabolic Illness Through prEcision nutRition (NCT NCT04148482)
NCT ID: NCT04148482
Last Updated: 2025-07-23
Results Overview
Measurement of blood glucose at regular intervals.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Day 1
Results posted on
2025-07-23
Participant Flow
Participant milestones
| Measure |
Genotype of Interest Group
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
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.
|
Control
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
Baseline characteristics by cohort
| Measure |
Genotype of Interest Group
n=12 Participants
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
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.
|
Control
n=10 Participants
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.
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Glucose at time 0
|
81.9 mg/dL
STANDARD_DEVIATION 11.7 • n=5 Participants
|
85.6 mg/dL
STANDARD_DEVIATION 8.3 • n=7 Participants
|
83.6 mg/dL
STANDARD_DEVIATION 10.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Measurement of blood glucose at regular intervals.
Outcome measures
| Measure |
Genotype of Interest Group
n=12 Participants
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
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.
|
Control
n=10 Participants
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.
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.
|
|---|---|---|
|
Glucose at Times 30min, 60min, 120min, 180min
180min
|
80.8 mg/dL
Standard Deviation 12.5
|
81.9 mg/dL
Standard Deviation 9.4
|
|
Glucose at Times 30min, 60min, 120min, 180min
30min
|
112.9 mg/dL
Standard Deviation 19.3
|
119.8 mg/dL
Standard Deviation 15.6
|
|
Glucose at Times 30min, 60min, 120min, 180min
60min
|
94.5 mg/dL
Standard Deviation 24.1
|
118.4 mg/dL
Standard Deviation 34.3
|
|
Glucose at Times 30min, 60min, 120min, 180min
120min
|
84.1 mg/dL
Standard Deviation 22.5
|
94.1 mg/dL
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Day 1Number of participants with preference for a high-fat meal.
Outcome measures
| Measure |
Genotype of Interest Group
n=12 Participants
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
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.
|
Control
n=10 Participants
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.
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.
|
|---|---|---|
|
High-fat Meal Preference
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Investigators 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.
Outcome measures
| Measure |
Genotype of Interest Group
n=12 Participants
Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.
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.
|
Control
n=10 Participants
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.
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.
|
|---|---|---|
|
Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline)
taurodeoxycholic acid at 120 minutes
|
10.4 fold-change from baseline
Standard Deviation 8.8
|
4.2 fold-change from baseline
Standard Deviation 4.0
|
|
Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline)
glycochenodeoxycholic acid at 120 minutes
|
6.7 fold-change from baseline
Standard Deviation 5.3
|
3.9 fold-change from baseline
Standard Deviation 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 120min, 240min, 360minPopulation: Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected.
Although these outcomes were initially proposed/intended, insufficient funds were available to collect or analyze these measures, and they were not ultimately collected.
Outcome measures
Outcome data not reported
Adverse Events
Genotype of Interest Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place