Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters, metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese subjects following an energy-restricted diet.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages between 20 and 45 years, and with regular menstrual cycles
- •Body Mass Index (BMI) between 27.5 and 39.9 kg/m2
- •Weight unchanged (± 3 kg) for the last 3 months
- •All subjects should have an overall physical and psychological condition that the investigator believes is in accordance with the overall aim of the study.
排除标准
- •Use of prescription medication
- •To suffer from any chronic metabolic or obesity related disease, hepatic or renal systemic disease: Hypertension, dislipidemia, type 1 or 2 diabetes, thyroid function disorders, cirrhosis, fatty liver, etc.
- •Food allergies or food intolerance expected to come up during the study
- •Special diets (Atkins, vegetarian, etc.) prior three months the start of the study.
- •Eating disorders
- •Surgically treated obesity
- •Pregnant or lactating women or planning to be pregnant in the next two months
- •Alcohol or drug abuse (based on clinical parameters)
结局指标
主要结局
Weight Loss
时间窗: Week 10 (end of treatment)
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Body composition and Anthropometric parameters
时间窗: Week 0 (Baseline)
Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Body composition and anthropometric parameters
时间窗: Week 10 (end of treatment)
Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Glucose metabolism parameters
时间窗: Week 10 (end of treatment)
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
Lipid metabolism biomarkers
时间窗: Week 10 (end of treatment)
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
次要结局
- Blood Pressure and Cardiovascular Risk biomarkers(Week 10 (end of treatment))
- Energy expenditure(Week 10 (end of treatment))
- Satiety(Week 10 (end of treatment))
- Serum inflammation biomarkers(Week 10 (end of treatment))
- Serum oxidative stress biomarkers(Week 10 (end of treatment))
- Adipose tissue gene profile and function analysis(Week 10 (end of treatment))
- Metabolomic and lipidomic profile(Week 10 (end of treatment))