Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight (MONW) Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gycaemic control
研究概览
简要总结
Asians tend to develop type 2 diabetes (T2D) at lower body mass index (BMI) levels and younger ages compared to other populations. This leads to a longer duration of suffering from long-term complications associated with the disease, ultimately resulting in shorter life expectancy. Notably, approximately 40% of newly diagnosed T2D cases in Asians occur in individuals considered lean, with a BMI reported to be less than 22 kg/m2. This phenomenon is termed the "Metabolically Obese Normal Weight" (MONW) phenotype. MONW individuals are characterized as having a normal body weight but exhibiting obesity-related metabolic disturbances, including excess body fat with ectopic fat deposition, insulin resistance, and dyslipidemia.
详细描述
Asian populations have higher prevalence of abdominal obesity, accounting for ~60% of the global diabetic population. Type 2 diabetes (T2D) developing at lower BMI levels and younger ages compared to Western populations, suggest underlying metabolic issues in Asian. A cluster of metabolically obese, normal weight (MONW) individuals are identified in 40% of newly diagnosed Asian T2D.
MONW individuals have normal body weight but exhibit obesity-related metabolic disturbances, such as excess body fat, insulin resistance, and dyslipidemia, predisposing them to develop metabolic symptoms such as T2D and cardiovascular disease. They also show reduced physical activity, lower aerobic capacity, low muscle quality and impaired thermogenesis. Elevated plasma amino acids are associated with insulin resistance, resembling obesity, diabetes and sarcopenia. Given the complex nature of MONW, further examination is needed for early diagnosis and effective prevention strategies. Increased protein intake is known to improve satiety, thermogenesis and muscle health, while enhancing insulin sensitivity and fat oxidation. High-protein diets can aid in weight loss and are often preferred over traditional calorie restriction for combating obesity. In our previous study, a 5% weight loss from calorie restriction improved body composition and metabolism in MONW individuals. Hence, this study aims to 1) better understand the physiology and energy balance of MONW individuals; 2) identify biomarkers for early diagnosis; and 3) examine the effects of high-protein diets on the metabolism of MONW individuals. The study will involve participants of Chinese descent, evaluating metabolic biomarkers in energy balance and the impact of different protein sources on their acute metabolic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.5 - 24.9 kg/m2
- •Non-diabetic
- •Blood pressure (≤140/90 mmHg)
- •<5% weight change in the past 6 months
- •Fasting triglyceride < 90 mg/dl and HOMA-IR ≤ 1.0 will be defined as healthy subjects
- •Fasting triglyceride ≥ 90 mg/dl and HOMA-IR > 1.0 will be defined as MONW subjects
排除标准
- •• Smoker or currently on nicotine therapy
- •Regularly consume alcohol >1 unit per day
- •On hypocaloric/hypercaloric diet aiming for weight loss/gain
- •An athlete or sportive person with regular exercising >3 times per week and >45 minutes per section.
- •Currently receiving therapy (e.g. insulin) or any medication/ treatment (including supplements) that may affect glucose and lipid metabolism, energy metabolism or body composition
- •Currently on steroids, protease inhibitors, or antipsychotics therapies
- •Has symptomatic Irritable Bowel Syndrome
- •Has glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Had major medical or surgical event requiring hospitalization within the preceding 3 months
- •Participated in drug trials within 3 months before the start of the study
- •Donated blood within 3 months before the start of the study
- •Has intolerances or allergies to any of the study foods (eg. anaphylaxis to glutens)
- •Pregnant (pregnancy test will be done), lactating, or planning to be become pregnant during the study period
- •Has active Tuberculosis (TB) or currently receiving treatment for TB
- •Has chronic infection or is known to suffer from or has previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- •Has claustrophobia, trypanophobia, or hemophobia
- •Unwilling to consume study foods
- •Inadequate fluency in the English language
- •Unable to understand the study procedures and signs forms providing written informed consent to participate in the study.
- •Is a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
研究组 & 干预措施
Normal protein diet
Animal based protein. 60% carbohydrates, 10% proteins and 30% lipids (i.e. 0.8g of protein/kg of body weight/day)
干预措施: Normal protein diet (Other)
Animal based high protein meal
40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day)
干预措施: Animal protein diet (Other)
Plant based high protein meal
40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day)
干预措施: Plant based diet (Other)
结局指标
主要结局
Gycaemic control
时间窗: Blood will be sampled at timepoints, t = 0minute(fasting), following the meal test,for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes),and pre- and post-exercise
The primary outcome in this study is the effect on glycaemic control (fasting glucose, insulin, insulin sensitivity).
Energy expenditure and fuel utilization
时间窗: Assessed for 9 hours in the whole body calorimeter room on visits 3, 4 and 5. 30 minute-RMR,3hour-DIT, 30minute-exercise-induced EE (or PAEE)); urine samples collected on 4 different sessions throughout the WBC
Metabolism will be assessed in the whole body calorimeter (WBC). Only one subject alone in the WBC room during the test. The subject can move around freely. O2 consumption and CO2 production will be detailed energy metabolism in different parameters, such as RMR, DIT, PAEE and NEAT.measured to calculate energy expenditure using Weir formulae Urine samples collected across 4 different sessions throughout the WBC stay to assess protein utilisation
Postprandial amino acids and proteomics profiles
时间窗: Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t=60 minutes.
To identify novel biomarkers and gain insights to investigate phenotypic differences of MONW individuals.
次要结局
- Postprandial profiles of lipid and inflammation(Blood will be sampled at timepoints, t = 0 minute (fasting), following the meal test, for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes), and pre- and post-exercise.)
- Measure of appetite regulation and postprandial gut hormones(Rate hunger and satiety immediately before (t=0 minute) and after meal (t=15, 30, 60, 120, 180, and 240 minutes))
- Measure of muscle and inflammation biomarkers after exercise bout(Blood samples were taken prior to the exercise and immediately after the 30-minute exercise)
- Baseline gut microbial populations and functions and relationship to the host's diet(1 stool sample collected during study,taken at baseline (between baseline visit and before first intervention visit). Can be collected in centre or at home using a stool kit. Kit contained stabilising reagents to stabilize DNA and RNA.)
研究者
Melvin Leow
Prof Melvin Leow Khee-Shing
Singapore Institute of Food and Biotechnology Innovation