An interventional study of Post prandial testing in PreDiabetes, Diabetes Mellitus, Type 2 and Healthy, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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.
Other: Post prandial testing
A variety of foods, supplements, and short prescriptive exercise will be tested to see which one helps mitigate the rise is postprandial glucose after eating carbohydrate containing foods.
Post prandial peak glucose levels
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.
Time frame: 3 hours
Post prandial glucose area under the curve (AUC)
AUC (\>baseline) within three hours measured by CGM in mg/dL during the 3 hours after each study meal.
Time frame: 3 hours
Glucose time to peak
The time in minutes from baseline to peak within 3 hours measured by CGM after each standardized meal.
Time frame: 3 hours
Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
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.
Time frame: 1 hour
Individual microbiome composition
Microbiome will be defined by using metagenomics assay to baseline samples
Time frame: Baseline
Changes in postprandial proteomic responses as measured in micro-sampling by Olink
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.
Time frame: 1 hour
Plan to share: Yes — The investigator plan to share de-identified data to both public repositories and integrated databases when the consent of data sharing is obtained. The analysis results will be shared with the publication.
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