Post Prandial Individual Responses to Different Foods

Stanford University

Status: Enrolling

Conditions: Healthy; Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Other: Post prandial testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06989164

80689

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Diet Cycles

Experimental group

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.

Treatment:

Other: Post prandial testing