To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Weight loss (kg)
研究概览
简要总结
This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
详细描述
Increasing the protein consumption promotes weight loss through several mechanisms. Diets high in protein promote energy expenditure through increased postprandial thermogenesis, increase total daily expenditure and increase satiety as compared to carbohydrate. The present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 to 60 years
- •Body mass index (BMI) ≥ 25 kg/m2 to 40 kg/m2
- •Subjects who have stable weight, i.e. who have not had more than ± 3 kg variation in their weight level in the 3 months prior to screening for this study.
- •Absence of significant disease or clinically significant medical history or physical examination during screening in the view of the investigator.
- •Subjects willing to provide written inform consent to participate in the study.
排除标准
- •Body mass index (BMI) > 40 kg/m2
- •Any patient taking/requiring drugs known to effect insulin resistance, lipids, vascular reactivity, during the intervention period would be excluded from the study
- •Patients on any drugs that change the weight or in conditions where dietary protein supplementation is contraindicated
- •Subjects who are consuming a high protein diet on randomization, to be excluded
- •Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc
- •Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs
- •Pregnancy & lactation
- •Patients having diagnosed with any of the following:
- •Type 2 diabetes mellitus
- •Cushing's disease
- •Severe end organ damage
- •Unwillingness to give written informed consent for participation in the study
研究组 & 干预措施
PACER diet
High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks.
干预措施: PACER Diet (Dietary Supplement)
Standard weight reducing diet
This group was prescribed Standard weight reducing diet to be followed for 8 weeks.
干预措施: Standard weight reducing diet (Other)
结局指标
主要结局
Weight loss (kg)
时间窗: 8 weeks
次要结局
- Lipid profile(8 weeks)
- Insulin resistance(8 weeks)
研究者
Dr Anoop Misra
Dr. Anoop Misra
Diabetes Foundation, India