Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Positive Area Under the Curve (pAUC) for Blood Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
NOURISH Diet to Self-Selected Diet
Participants in this arm will be consuming the NOURISH diet first (During Week 2 of the intervention), followed by their self-selected diet (baseline/control) in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app.
干预措施: NOURISH Diet (Other)
Self Selected Diet to NOURISH Diet
Participants in this arm will be consuming self-selected meals (baseline/control) first (During Week 2 of the intervention), followed by the NOURISH diet in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app.
干预措施: NOURISH Diet (Other)
Self Selected Diet to NOURISH Diet
Participants in this arm will be consuming self-selected meals (baseline/control) first (During Week 2 of the intervention), followed by the NOURISH diet in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app.
干预措施: Self-Selected Diet (Control) (Other)
NOURISH Diet to Self-Selected Diet
Participants in this arm will be consuming the NOURISH diet first (During Week 2 of the intervention), followed by their self-selected diet (baseline/control) in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app.
干预措施: Self-Selected Diet (Control) (Other)
结局指标
主要结局
Change in Positive Area Under the Curve (pAUC) for Blood Glucose
时间窗: During Week 2, Week 3
Upon analysis of the CGM data graphs, the area under the curve will be analyzed. The goal is to observe the difference in glucose levels when participants consume NOURISH meals versus the self-selected diet. Higher pAUC values indicate higher average blood glucose and possibly decreased glycemic control, whereas lower pAUC values indicate lower average blood glucose and possibly increased glycemic control.
次要结局
- Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline(During Week 2, Week 3, Week 4)
- Adherence to NOURISH Diet(1 week)
研究者
Minal Moharir
Clinical Assistant Professor, Medicine - Primary Care and Population Health
Stanford University