NCT06488339尚未招募不适用
Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Weight
研究概览
简要总结
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years
- •Body mass index more than 23 kg/m2
- •No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
- •Wiling to attend the study
排除标准
- •Allergic to protein, grains, guar gum
- •Take medicine, supplement, herbal substance for weight control within 1 month
- •During intermittent fasting
- •Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
- •Cushing syndrome's
- •Pregnancy and lactation
结局指标
主要结局
Weight
时间窗: 8 weeks
Weight of volunteers (kg)
次要结局
- Skin fold thickness(8 weeks)
- Body mass index(8 weeks)
- Percentage of body fat(8 weeks)
- Hemoglobin A1C(8 weeks)
- Total protein(8 weeks)
- Percentage of visceral fat(8 weeks)
- Percentage of subcutaneous fat(8 weeks)
- Waist Circumference(8 weeks)
- Percentage of muscle(8 weeks)
- Hip Circumference(8 weeks)
- Total cholesterol(8 weeks)
- Low density lipoprotein(8 weeks)
- Triglycerides(8 weeks)
- 8-hydroxy-2-deoxyguanosine(8 weeks)
- High density lipoprotein(8 weeks)
- Fasting blood sugar(8 weeks)
- Hemoglobin(8 weeks)
- SIRT1 (NAD-dependent deacetylase sirtuin-1)(8 weeks)
- Blood urea nitrogen(8 weeks)
- Alanine aminotransferase(8 weeks)
- Creatinine(8 weeks)
- Aspartate transaminase(8 weeks)
- Alkaline phosphatase(8 weeks)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
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