Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post prandial peak glucose levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diet Cycles
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.
干预措施: Post prandial testing (Other)
结局指标
主要结局
Post prandial peak glucose levels
时间窗: 3 hours
Delta glucose peak within 3 hours after consuming the standard meal - peak glucose value minus baseline glucose value at time 0 measured by CGM in mg/dL.
Post prandial glucose area under the curve (AUC)
时间窗: 3 hours
AUC (\>baseline) within three hours measured by CGM in mg/dL during the 3 hours after each study meal.
次要结局
- Glucose time to peak(3 hours)
- Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)(1 hour)
- Individual microbiome composition(Baseline)
- Changes in postprandial proteomic responses as measured in micro-sampling by Olink(1 hour)
研究者
Yue Wu
Post doctoral
Stanford University