Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

Официальное название

Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study

Обзор

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

Подробное описание

This clinical trial evaluates the impact of culturally tailored, American Diabetes Association (ADA)-compliant meals on the glycemic control of Asian Indian and Filipino individuals with Type 2 Diabetes Mellitus (T2DM). This study leverages a crossover design to compare glycemic responses during two distinct dietary phases: a self-selected diet phase (baseline/control/routine diet) and an intervention phase featuring NOURISH meals. NOURISH Meals will be delivered to designated pick-up points on the Stanford campus and Stanford clinics. Participants will be equipped with Continuous Glucose Monitors (CGMs) to track glucose trends across the study and will be required to keep a food log through Tastermonial, enabling detailed analysis of postprandial glucose responses and key metrics.

Вмешательства

• Другое NOURISH Diet
  NOURISH meals will be prepared by NOURISH chefs for seven days. Both South Asian and Filipino meal plans will be prepared, vegetarian, vegan and non-vegetarian options available for all. Participants will pick-up NOURISH meals at a Stanford facility and consume three meals (breakfast, lunch, and dinner) and two snacks over one week. There will be no caloric restriction, the calories in each meal will be informed by the average intake for the participants gender and BMI.
• Другое Self-Selected Diet (Control)
  The participants will eat their routine meals without any involvement of the investigators. Participants will be required to wear the CGM during this time and keep a detailed food log through Tastermonial.

Первичные конечные точки

• Change in Positive Area Under the Curve (pAUC) for Blood Glucose [Срок оценки: During Week 2, Week 3]

Вторичные конечные точки (2)

• Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline [Срок оценки: During Week 2, Week 3, Week 4]
• Adherence to NOURISH Diet [Срок оценки: 1 week]

Критерии участия

Критерии включения

• Self-identification as Asian Indian or Filipino
• Diagnosed with T2DM
• Pick up and consume personally tailored cultural food and meal options for 1 week
• Willing to wear a CGM for 30 days

Критерии исключения

• Currently taking insulin
• Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat
• Those who, in the opinion of the investigators, cannot reliably complete the study protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT06836479 · 78525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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