The Impact of Dietary Protein Sources on Glycemic Variability in Overweight or Obese Individuals: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Change in Mean Amplitude of Glycemic Excursion (MAGE)
研究概览
简要总结
This goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention.
The main question it aims to answer is:
Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet?
Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study. They will wear a Continuous Glucose Monitor (CGM) throughout the study, engage in weekly clinical assessments, and record their daily dietary intake.
详细描述
Diabetes stands as one of the most rapidly escalating health challenges of the 21st century. Type 2 diabetes, which represents over 90% of all diagnosed cases, is the predominant form of the disease, with obesity and being overweight identified as key risk factors. The mainstay of prevention and management for Type 2 diabetes continues to be dietary intervention and nutritional therapy. Current dietary strategies for Type 2 diabetes focus predominantly on the regulation of fat and carbohydrate intake, while the influence and underlying mechanisms of dietary protein on glucose metabolism are not yet fully comprehended.
A randomized, open-label, parallel-controlled clinical trial, by strictly controlling the source of protein, will be performed to evaluate the effects of a plant-based diet on glycemic variability and other metabolic outcomes in individuals who are overweight or obese, in comparison to an animal-based diet. Eligible participants will be randomly allocated in a 1:1 ratio to either the plant-based or animal-based diet group for a 3-week intervention.
During the intervention, participants in the plant-based diet group will receive three daily meals for three weeks.Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The primary sources of plant protein will include soybeans, lentils, nuts, grains, and seaweed. Conversely, the animal-based diet group will also be provided with three daily meals for three weeks, with the same caloric distribution, but sourcing their protein from animal products such as poultry, beef, pork, fish, eggs, and dairy.
Participants are required to cooperate in completing the following tasks:
- Daily dietary record: Participants are to meticulously track their daily food consumption.
- Continuous 24-hour glucose monitoring and data logging: Subjects are to undergo continuous monitoring of blood glucose levels throughout a 24-hour period, with all data accurately recorded.
- Physical examination: This will include assessments of height, weight, waist-to-hip circumference ratio, blood pressure, and body composition.
- Biological sample collection: Samples to be collected include blood, urine, and stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
This trial is an open-label study. Given that dietary intervention will be administered to all participants, it is challenging to implement blinding for the participants. However, throughout the study, the individuals involved in the preparation and distribution of meals, along with those conducting the statistical analysis, will remain blind to the group assignments of the participants.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 20-65 years.
- •Body Mass Index (BMI) greater than 25kg/m
- •Capable of using a smartphone application daily for taking photos and recording dietary intake.
- •Maintained stable body weight over the past three months with a regular routine.
- •Possess self-care ability for independent living.
- •Not currently participating in any other clinical research projects.
- •Signed the informed consent form and willing to adhere to and complete the entire research process.
排除标准
- •With diagnosed diabetes.
- •With severe cardiovascular or cerebrovascular diseases (e.g., angina, myocardial infarction, or stroke) or cancer.
- •Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician.
- •Participating in weight loss treatments.
- •History of severe gastrointestinal diseases or gastrointestinal surgery within the past 12 months.
- •Those with allergic reactions to common foods (for example, eggs, nuts, grains) or those who are lactose intolerant.
- •Women who are pregnant or plan to become pregnant.
- •Diagnosis of HIV, hepatitis B or C, or active tuberculosis.
- •Special groups who are specifically unsuitable for a diet consisting of whole plant proteins.
- •Patients who are unwilling or unable to give informed consent.
结局指标
主要结局
Change in Mean Amplitude of Glycemic Excursion (MAGE)
时间窗: From enrollment to the end of intervention at 3 weeks
Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE).
次要结局
- Change in glycemic variability(From enrollment to the end of intervention at 3 weeks)
- Change in fasting insulin(From enrollment to the end of intervention at 3 weeks)
- Change in Area Under Curve (AUC)(From enrollment to the end of intervention at 3 weeks)
- Change in blood lipids(From enrollment to the end of intervention at 3 weeks)
- Change in gut microbiome(From enrollment to the end of intervention at 3 weeks)
- Change in renal function(From enrollment to the end of intervention at 3 weeks)
- Change in systolic blood pressure(From enrollment to the end of intervention at 3 weeks)
- Change in diastolic blood pressure(From enrollment to the end of intervention at 3 weeks)
- Change in body weight(From enrollment to the end of intervention at 3 weeks)
- Change in uric acid(From enrollment to the end of intervention at 3 weeks)
- Change in total daily time below range(From enrollment to the end of intervention at 3 weeks)
- Change in range of total daily time(From enrollment to the end of intervention at 3 weeks)
- Change in glycemic standard deviation(From enrollment to the end of intervention at 3 weeks)
- Change in waist-to-hip ratio(From enrollment to the end of intervention at 3 weeks)
- Change in body composition(From enrollment to the end of intervention at 3 weeks)
- Change in fasting blood-glucose(From enrollment to the end of intervention at 3 weeks)
- Change in mean glucose levels(From enrollment to the end of intervention at 3 weeks)
- Change in total daily time above range(From enrollment to the end of intervention at 3 weeks)
- Change in insulin sensitivity(From enrollment to the end of intervention at 3 weeks)
- Change in β cell function(From enrollment to the end of intervention at 3 weeks)
- Change in Large Amplitude of Glycemic Excursions (LAGE)(From enrollment to the end of intervention at 3 weeks)
研究者
Jie Li
Professor, Deputy director of global health research center
Guangdong Provincial People's Hospital