Clinical trial NCT06989164: Post Prandial Individual Responses to Different Foods
Official title: Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be asked to consume pre-portioned foods on different days as the first meal of the day, use a CGM, and take saliva and micro samples of blood before and after each meal. Food, supplements, and short exercise will be tested to see the post prandial effects.
Primary purpose: PREVENTION

Brief summary: This study aims to understand why people respond differently to the same foods, especially when it comes to changes in blood sugar after eating. A continuous glucose monitors (CGMs) will be used to observe how individuals respond to specific meals and drinks (e.g., Oral Glucose Tolerance Test, OGTT). By studying these patterns, the investigators hope to identify different types of metabolism and see if certain foods or food ingredients (like fiber, amino acids, or vinegar) can help control blood sugar better for specific groups. This research will help lay the groundwork for personalized dietary advice based on a person's unique biology.

Detailed description: Participants in the study will be provided with a continuous glucose monitor (CGM) and pre-measured cooked rice to test with different potential mitigators: fiber, acid, amino acid (e.g., leucine), whole protein, and exercise. Each of these conditions will be tested on a different day following strict instructions. For some of these tests, participants will be asked to collect a blood microsample and a saliva sample before and after eating the test meal. A stool sample will be collected at baseline.

Eligibility criteria: Inclusion Criteria:

* BMI (body mass index) \>19 kg/m2 but \< 45 kg/m2
* HbA1c \< or equal to 7.0% while not on antihyperglycemic medications
* Be willing to provide written informed consent for all study procedures.
* Able to commute to Stanford campus for on-site visits

Exclusion Criteria:

* recent (\<6mos) CVD (cardiovascular disease) event
* active malignancy
* kidney/liver disease
* pregnancy/lactation
* chronic inflammatory disease
* eating disorder
* bariatric surgery
* history of acute pancreatitis
* current use of antihyperglycemic, diabetogenic, or weight loss medications
* heavy alcohol use
* physical activity \>2 hours/day
* inability to come to Stanford CTRU (Clinical and Translational Research Unit) for metabolic testing

Primary outcomes:
measure: Post prandial peak glucose levels
timeFrame: 3 hours
measure: Post prandial glucose area under the curve (AUC)
timeFrame: 3 hours
Secondary outcomes:
measure: Glucose time to peak
timeFrame: 3 hours
measure: Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
timeFrame: 1 hour
measure: Individual microbiome composition
timeFrame: Baseline
measure: Changes in postprandial proteomic responses as measured in micro-sampling by Olink
timeFrame: 1 hour
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: