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NCT Number: NCT06989164

Post Prandial Individual Responses to Different Foods

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Location status: Recruiting

Location contact

Dalia Perelman, MS, RD, CDE

SUB_INVESTIGATOR

Sabrina Chun Johnston, MS, RD

CONTACT

[email protected]

(650) 725-0169

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post prandial testing

Other

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.

Primary outcomes

  1. Post prandial peak glucose levels

    Time frame: 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.

  2. Post prandial glucose area under the curve (AUC)

    Time frame: 3 hours

    AUC (>baseline) within three hours measured by CGM in mg/dL during the 3 hours after each study meal.

Secondary outcomes

  1. Glucose time to peak

    Time frame: 3 hours

    The time in minutes from baseline to peak within 3 hours measured by CGM after each standardized meal.

  2. Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)

    Time frame: 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.

  3. Individual microbiome composition

    Time frame: Baseline

    Microbiome will be defined by using metagenomics assay to baseline samples

  4. Changes in postprandial proteomic responses as measured in micro-sampling by Olink

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 25, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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