CTRI/2024/07/070656招募中4 期
Comparison of the effectiveness of different regimens of intermittent fasting in overweight and obese adults.
Maulana Azad Medical College and Associated Hospitals1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in body weight, body mass index
研究概览
简要总结
This parallel group interventional study is designed to compare the effect of Alternate Day Fasting (ADF) vs The 5:2 diet vs control group, on various anthropometric, biochemical, clinical and nutritional parameters and quality of life in overweight and obese adults in a 12-week comprehensive behavioural weight loss intervention.
Hypothesis: Alternate Day Fasting (ADF) and the 5:2 Diet prescribed to overweight and obese adults would lead to weight loss and improvement in metabolic markers and quality of life compared to the individuals in control group under standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Body Mass Index equals or greater than 23 kilograms per square meter (as per WHO Asian BMI classification),
- •Able to give informed consent,
- •Not planning to relocate within 6 months of the study, 4.
排除标准
- •Individuals suffering from disorders like Celiac disease, uncontrolled thyroid disorder, anorexia bulimia.
- •Individuals with comorbid conditions in which dietary restrictions will be detrimental like individuals with Stroke, Cardiomyopathy, Coronary artery disease, other Cardio-vascular disease, Chronic Obstructive Pulmonary Disease, Alzheimers disease, Depression.
- •Individuals who have previous weight loss surgery, moderate or severe chronic hepatorenal diseases or cardio-cerebrovascular diseases, current acute complications of diabetes, such as diabetic ketosis, hyperglycaemia and hypertonicity in the past 3 months, stress diseases such as surgery, trauma, and cardiovascular and cerebrovascular events, and mental disorders requiring antipsychotic drugs.
- •Women who are lactating, pregnant or planning for pregnancy.
- •Individuals undergoing some weight loss intervention or have undergone weight loss intervention within 3 months tim.
结局指标
主要结局
Change in body weight, body mass index
时间窗: At Baseline 0 week | At Midline 6 weeks | At Endline 12 weeks
次要结局
- reduction in body fat, visceral fat, improvement in waist to hip ratio(At Baseline 0 week)
- Lipid levels, Fasting Blood Glucose, HbA1C, HOMA IR, Fasting insulin, Ferritin, IL-6, Adiponectin, Total energy intake. Improvement in quality of life and parameters like physical, emotional and social well-being(At Baseline 0 week)
研究者
Dr Sandeep Garg
ualana Azad Medical College and Associated Hospitals
研究点 (1)
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