NCT06989164

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Oct 2025Nov 2028

First Submitted

Initial submission to the registry

May 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

May 13, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 hours

Secondary Outcomes (4)

  • Glucose time to peak

    3 hours

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

    1 hour

  • Individual microbiome composition

    Baseline

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

    1 hour

Study Arms (1)

Diet Cycles

EXPERIMENTAL

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

Interventions

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.

Diet Cycles

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doctoral

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 25, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Time Frame
De-identified data will be shared with the future publications.
Access Criteria
De-identified data will be shared in public repositories. Metabolomics, microbiome, proteomics, and CGM measured glycemic response will be open to public access through the corresponding repositories.

Locations