The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men: a Factorial Randomized Controlled Trial (FlexiFast Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in glucose homeostasis
研究概览
简要总结
The goal of this factorial randomized controlled trial is to find out whether time-restricted eating and flexitarian diet (on its own and combined) can improve cardiometabolic health markers in normal weight, young men with metabolic abnormalities?
Participants will be assigned to four groups: control, flexitarian, time-restricted eating and time-restricted eating + flexitarian. Investigators will look for men with elevated fasting blood glucose or blood lipids level or blood pressure and with normal body weight and waistline. Participants from the flexitarian group will be asked to follow a diet that has been carefully designed for them by the PI and dietitian for the period of 8 weeks. Participants from the control group will receive general healthy eating recommendations.
We aim to investigate if the experiment had any effect on changes in metabolic, inflammation and nutritional markers, blood pressure and body weight and composition. Also, the effect of diets on men's sleep, general wellbeing and satisfaction with treatment will be investigated.
The proposed study can test a potentially effective nutritional intervention which is feasible to adopt and sustainable (in line with recent planetary diet recommendations). Confirming its effectiveness can fill the research gap, providing new knowledge and approach to the prevention and treatment of metabolic abnormalities in young, lean men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •Normal body weight
- •At least one of metabolic abnormalities (elevated fasting glucose level - but not diabetes, elevated blood lipids, elevated blood pressure)
排除标准
- •Age <18 and >40 years
- •Overweight or obesity (BMI>25 kg/m2)
- •WC > 94cm
- •Alcohol >14 units/week
- •On medication
- •Diabetes or other chronic diseases
- •Vegetarians or vegans
- •Don't own or unable to use a Smartphone with Apple iOS or Android OS
结局指标
主要结局
Change in glucose homeostasis
时间窗: baseline, after 8 weeks and after 20 weeks from baseline
Change in fasting glucose concentration \[mg/dL\]. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer.
次要结局
- Change in waist circumference(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in high-density lipoprotein (HDL) cholesterol(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in body weight(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in insulin concentration(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in waist-to-hip ratio(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in nutrition markers-2(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in haemoglobin glycosylated (HbA1c) concentration(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in low-density lipoprotein (LDL) cholesterol(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in serum triglycerides (TG)(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in body mass index (BMI)(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in body fat mass percentage(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in inflammatory markers-1(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in inflammatory markers-2(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in nutrition markers-1(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in total cholesterol (TC)(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in visceral adipose tissue (VAT)(baseline, after 8 weeks and after 20 weeks from baseline)
- Change in systolic and diastolic blood pressure(baseline, after 8 weeks and after 20 weeks from baseline)
研究者
Marta Lonnie
Principal Investigator
University of Warmia and Mazury in Olsztyn