Post Prandial Individual Responses to Different Foods

Not Applicable

Not yet recruiting

• Conditions: PreDiabetes; Diabetes Mellitus, Type 2; Healthy

• Registration Number: NCT06989164
• Lead Sponsor: Stanford University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-15
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post prandial peak glucose levels	3 hours	Delta glucose peak within 3 hours after consuming the standard meal - peak glucose value minus baseline glucose value at time 0 measured by CGM in mg/dL.
Post prandial glucose area under the curve (AUC)	3 hours	AUC (\>baseline) within three hours measured by CGM in mg/dL during the 3 hours after each study meal.

Secondary Outcome Measures

Name	Time	Method
Glucose time to peak	3 hours	The time in minutes from baseline to peak within 3 hours measured by CGM after each standardized meal.
Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)	1 hour	Dry blood samples will be collected by micro-sampling before and 1 hour after the standardized meals. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites.
Individual microbiome composition	Baseline	Microbiome will be defined by using metagenomics assay to baseline samples
Changes in postprandial proteomic responses as measured in micro-sampling by Olink	1 hour	Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States