Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visceral adiposity index (VAI)
研究概览
简要总结
This study proposes to examine the independent and combined effects of an 8-week home-based, equipment-free HIIT exercise intervention with/without Mediterranean diet through ghrelin-mediated alteration in overweight and obese metabolic women to improve cardiovascular-risk related markers and metabolic risk factors.
详细描述
This is a randomised-controlled study investigating the independent and combined effects of a home-based, equipment-free high intensity interval training (HIIT) exercise intervention with/without the Mediterranean diet (MedDiet) through ghrelin-mediated alteration on body composition, cardiovascular risk-related markers, metabolic markers and obesity-related hormones in postmenopausal women. The intervention will last for 8-weeks, with three arms comprising of 1) exercise only (Ex); 2) exercise and MedDiet (Ex+MedDiet); 3) control (no intervention).
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
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants >45-65 years of age
- •Body mass index (BMI) >25.0 - 35.0
- •Postmenopausal (with spontaneous amenorrhea for the last 12 months)
- •Healthy (no known diseases)
- •Physically inactive (IPAQ score - category I and not engaged in at least 60 min/week of structured exercise during the previous 6 months)
- •Generally well enough to exercise.
排除标准
- •Any inclusion criteria not met
- •Abnormal ECG
- •Current smokers
- •Current or history of substance abuse and/or excess alcohol intake
- •Cardiovascular disease
- •Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- •Kidney disease
- •Liver disease
- •Pancreatitis
- •On hormone therapy for <6 months
- •Prescribed anti-hypertensive or beta-blocker medication
结局指标
主要结局
Visceral adiposity index (VAI)
时间窗: Baseline to 8 weeks
Assessed at baseline and post-intervention (Week 1 and Week 8). VAI calculated based on their waist circumference, BMI, triglycerides and HDL cholesterol levels. Waist circumference will be recorded in centimetres. BMI will be combined based on weight (kilograms) and height (metres) as kg/m\^2. Triglycerides and HDL cholesterol levels will be assessed from fasting blood collected from the antecubital vein via venepuncture. Triglycerides and HDL will be recorded in mmol/L.
Inflammatory markers
时间窗: Baseline to 8 weeks
Assessed at baseline and post-intervention (Week 1 and Week 8). IL-6, CRP, IL-10, TNF-α will be assessed from fasting blood collected from the antecubital vein via venepuncture.
Blood lipid levels
时间窗: Baseline to 8 weeks
Assessed at baseline and post-intervention (Week 1 and Week 8). Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol will be assessed from fasting blood collected from the antecubital vein via venepuncture. All blood lipids will be recorded in mmol/L.
Blood pressure
时间窗: Baseline to 8 weeks
Assessed at baseline and post-intervention (Week 1 and Week 8). Systolic and diastolic blood pressure will be obtained from the participant's left arm after resting for at least 10 minutes. Blood pressure will be recorded in mmHg.
Insulin resistance index (HOMA-IR)
时间窗: Baseline to 8 weeks
Assessed at baseline and post-intervention (Week 1 and Week 8). Calculated based on blood glucose levels (mmol/L) and insulin (pmol/L) from fasting blood collected from the antecubital vein via venepuncture.
次要结局
- Circulatory levels of ghrelin(Baseline to 8 weeks)