Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This is a pilot study to determine the feasibility of studying the Fasting-Mimicking Diet (FMD), a dietary approach that involves the consumption of a specifically formulated, calorie-restricted nutrition regimen with a customized macronutrient composition, ratio, and quantity over a 5- day period, on a larger scale in Asian Americans with prediabetes and to examine the preliminary effects of the diet in study participants.
The main questions the study aims to answer are:
- What are the recruitment, adherence, and attrition rates of eligible participants into the study?
- Does one FMD cycle result in changes in fasting blood glucose levels and physical measurements in study participants?
Participants will be asked to undergo one cycle of FMD (for 5 days), fill out surveys, and come in for a pre-FMD and post-FMD study visit, during which physical measurements and fasting blood glucose and ketone levels will be measured.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identify as Asian American
- •Diagnosed with prediabetes according to at least one of the following:
- •HbA1C 5.7%-6.4%
- •Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L )
- •Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours
排除标准
- •Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions
- •Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
- •Individuals who are pregnant or breastfeeding
- •Individuals with anaphylaxis food allergies
- •Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- •Individuals who have completed the FMD in the past year
研究组 & 干预措施
Fasting Mimicking Diet (FMD)
The fasting-mimicking diet (FMD) group will be instructed on the benefits and use of the FMD kit. Participants will be given one 5-day FMD kit at their baseline visit. They will be instructed to follow the kit, and only eat its items, for five consecutive days and to report back for a follow-up visit and measurements at the end of their 5 days before returning to their normal diet.
干预措施: Fasting Mimicking Diet (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: up to 6 months
Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month.
Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial
时间窗: up to 6 months
Willingness to participate in a future full FMD clinical trial (which would have 4 FMD cycles + additional study appointments at 4 months after the last FMD cycle) will also be assessed via survey at the conclusion of their participation in this pilot.
Adherence rate
时间窗: up to 6 months
Study adherence will be assessed based on the participant's changes in fasting blood glucose and blood ketone levels measured pre- vs. post- Fasting Mimicking Diet (FMD); a post-FMD survey asking about adherence to the FMD; and attending the follow-up study appointment. The survey will also ask for participants' feedback on their experiences of the trial, including adverse events, and, if applicable, reasons for non-adherence, to enable further study optimization.
Attrition rate
时间窗: up to 6 months
Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started.
次要结局
- Change in ketone levels(Pre v. post 5-day FMD cycle)
- Change in fasting blood glucose levels(Pre v. post 5-day FMD cycle)
- Change in percent body/visceral fat(Pre v. post 5-day FMD cycle)
- Change in blood pressure(Pre v. post 5-day FMD cycle)
- Change in body mass index(Pre v. post 5-day FMD cycle)
- Change in waist circumference(Pre v. post 5-day FMD cycle)
研究者
Hannah Lui Park
Associate Professor
University of California, Irvine