Post Prandial Individual Responses to Different Foods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Post prandial testing.
- Who it may be relevant to
- Registry conditions: PreDiabetes, Diabetes Mellitus, Type 2, Healthy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes
Overview
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.
Interventions
- 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.
Primary outcome measures
- Post prandial peak glucose levels [Time frame: 3 hours]
- Post prandial glucose area under the curve (AUC) [Time frame: 3 hours]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT06989164 · 80689