Singapore Healthy Alternative Protein Evaluation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in metabolic health risk indicators
研究概览
简要总结
The overall aim of this randomized controlled trial is to investigate the effects of consuming a Plant-Based Meat alternative Diet (PBMD) compared to an Animal-Based Meat Diet (ABMD) on cardiometabolic health and protein homeostasis in Chinese men and women in Singapore. This will be achieved through the following specific objectives: (1) To evaluate the effects of dietary protein source on metabolic health and glycemic control(2) To evaluate the effects of dietary protein source on risk factors of cardiovascular diseases (3) To evaluate the effects of dietary protein source on protein homeostasis and metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Chinese males and females
- •2. Age \> 30 to \/= 5.4 and \/= 5.7 and \
排除标准
- •Obese: BMI (>/= 27.5 kg/m2) and/or waist circumference (>/= 102 cm for male; >/= 88 cm for female)
- •Significant weight change (± 5 % body weight) during the past 3 months
- •Past bariatric surgery
- •Women who are pregnant, lactating or planning pregnancy
- •History or known present diagnosis of cardiovascular (i.e.hypertension (systolic/diastolic blood pressure: >/= 140/90 mmHg), endocrine (i.e. type 1 and type 2 diabetes mellitus), gastrointestinal, hematological (G6PD and coagulation disorders), hepatic (hepatitis B and C), malignant, renal, respiratory, thyroid or other relevant disorders which may affect the outcomes of interested in consultation with the researchers involved
- •Prescribed and regularly taking western or traditional medicine which may affect the outcomes of interest in consultation with the researchers involved
- •History or present diagnosis of HIV and/or tuberculosis.
- •Drug abuse within the last 5 years
- •Taking dietary supplements which may affect study outcomes one month prior to their first visit (e.g. protein supplements, omega-3/6 supplements or other nutritional supplements such as Ensure, Anlene etc.)
- •Following any special diets which may interfere with intervention procedures (for medical, aesthetic or religious reasons)
- •Allergy to nuts, seeds, legumes (soy, pea), cereal (wheat gluten), beef, pork, chicken or any other ingredients present in foods provided for intervention
- •Excessive alcoholic beverage consumption > 2 servings per day (1 serving is defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
- •Smoking (cigarette, e-cigarette, cigar, pipe) or vaping
- •Exercising vigorously over the past 3 months
- •Staff of Prince September Pte. Ltd. (Pinduoduo Inc.) and/or Singapore Institute of Food and Biotechnology Innovation (SIFBI)
结局指标
主要结局
Change in metabolic health risk indicators
时间窗: Day -2 (from Week 0) to Day 12. 14 days in total
14-day continuous blood glucose monitoring (subgroup; n = 48)
Change in cardiovascular health risk indicators
时间窗: Pre- and Post-intervention (Week 8)
Insulin
次要结局
- Change in inflammation-related risk indicators(Pre- and Post-intervention (Week 8))
- Change in body composition(Pre- and Post-intervention (Week 8))
- Change in protein metabolism-related biomarkers in plasma/serum(Pre- and Post-intervention (Week 8))
- Change in anthropometric measurements(Pre- and Post-intervention (Week 8))
研究者
JeyaKumar Henry
Deputy Executive Director
Clinical Nutrition Research Centre, Singapore