Effects of Short-term Very Low-calorie Diets on Cardiometabolic Health Markers in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Fasting blood glucose
研究概览
简要总结
To investigate the effects of a short-term (1-week) nutritional intervention in healthy individuals using very low-calorie (fasting-mimicking) diets with different protein content on markers of cardiometabolic health and autophagy.
详细描述
The aim of this project is to investigate the metabolic effects of a short-term (1-week) nutritional intervention in healthy humans using very low-calorie (fasting-mimicking) diets with low and high protein content on key cardiometabolic outcomes (with blood glucose as a primary outcome) and autophagy, oxidative stress, inflammation, functional measures of cardiovascular health, body composition, and faecal markers for gut microbiome diversity (secondary outcomes).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Participant is willing and able to comply with the requirements of the study protocol
- •Aged between 18 and 65 years
- •Healthy individual
排除标准
- •A BMI <18 or >35 kg/m2
- •Regularly skipping breakfast
- •On an energy-restricted diet
- •Taking medication to control appetite
- •Eating Attitudes Test (EAT-26) score >20 as self-reported marker of symptoms and concerns characteristic of eating disorders
- •Active metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
结局指标
主要结局
Fasting blood glucose
时间窗: Day 0, Day 8
To determine the impact of very low-calorie diets on fasting blood glucose concentration and the addition of low and high protein
次要结局
- Measure circulatory autophagy marker Beclin-1(Day 0, Day 8)
- Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3)(Day 0, Day 8)
- Measure cardiometabolic health via insulin levels(Day 0, Day 8)
- Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels(Day 0, Day 8)
- Measures of cardiovascular health with autonomic function (heart rate)(Day 0, Day 8)
- Measure circulatory autophagy proteins (ATGs)(Day 0, Day 8)
- Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels(Day 0, Day 8)
- Functional measures of cardiovascular health with heart rate(Day 0, Day 8)
- Faecal markers for gut microbiome diversity(Day 0, Day 8)
- Urine markers of protein metabolism(Day 0, Day 8)
- Measure circulatory inflammation via C-reactive protein levels(Day 0, Day 8)
- Measure of cardiovascular health with blood pressure(Day 0, Day 8)
- Functional measures of cardiovascular health(Day 0, Day 8)
- Measures of cardiovascular health with autonomic function (blood pressure)(Day 0, Day 8)
- Body composition(Day 0, Day 8)
研究者
Kostas Tsintzas
Professor of Human Physiology
University of Nottingham