PreDiabetesNCT06989164
Post Prandial Individual Responses to Different Foods
A study testing Post prandial testing in people with PreDiabetes and Diabetes Mellitus, Type 2, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- Post prandial testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- recent (<6mos) CVD (cardiovascular disease) event
- active malignancy
- kidney/liver disease
- pregnancy/lactation
- chronic inflammatory disease
- eating disorder
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94304
Sabrina Chun Johnston, MS, RD, (650) 725-0169, csjohn@stanford.edu
Dalia Perelman, MS, RD, CDE
About this study
Official title: Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes
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.
Read the 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.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- Post prandial testing
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post prandial testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Post prandial testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 hours
Secondary outcomes (4)
Glucose time to peak
The time in minutes from baseline to peak within 3 hours measured by CGM after each standardized meal.
Measured: 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.
Measured: 1 hour
Individual microbiome composition
Microbiome will be defined by using metagenomics assay to baseline samples
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Wu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989164
- Sponsor's protocol ID
- 80689
- Status last verified
- Nov 2025
- First submitted
- 13 May 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes
- ClinicalTrials.gov ID
- NCT06989164
- Acronym / sponsor ID
- 80689
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet Cycles | Experimental | Other: Post prandial testingParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- recent (<6mos) CVD (cardiovascular disease) event
- active malignancy
- kidney/liver disease
- pregnancy/lactation
- chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post prandial testingA 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. | Other | Diet Cycles |
Primary outcome
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.
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.
4 secondary outcomes
Glucose time to peak
Time frame: 3 hours
Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
Time frame: 1 hour
Individual microbiome composition
Time frame: Baseline
Changes in postprandial proteomic responses as measured in micro-sampling by Olink
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post prandial testing in people with PreDiabetes and Diabetes Mellitus, Type 2, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post prandial peak glucose levels (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.