Post Prandial Individual Responses to Different Foods

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Post prandial peak glucose levels [Срок оценки: 3 hours]
• Post prandial glucose area under the curve (AUC) [Срок оценки: 3 hours]

Вторичные конечные точки (4)

• Glucose time to peak [Срок оценки: 3 hours]
• Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS) [Срок оценки: 1 hour]
• Individual microbiome composition [Срок оценки: Baseline]
• Changes in postprandial proteomic responses as measured in micro-sampling by Olink [Срок оценки: 1 hour]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT06989164 · 80689

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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