Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- body composition(DXA)
研究概览
简要总结
The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 30-55 years
- •grade II overweight (BMI≥27 but <30 kg/m2)
- •not to be adhered to any calorie restriction diet
- •not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study
排除标准
- •suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
- •having undergone bariatric surgery and/or intestinal resection
- •breastfeeding and pregnancy.
- •not to give their signed, informed consent to be included in the study.
研究组 & 干预措施
CLA group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
干预措施: Tonalin® (Dietary Supplement)
Placebo group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo, P group.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
body composition(DXA)
时间窗: 0, 3, 6 months
次要结局
- anthropometric parameters(0,1, 2, 3, 4, 5 and 6 month)
- Biochemical parameters(0, 3 and 6 month)
- HOMA-Index(0, 3, 6 month)
研究者
Ignacio Galicia
Director
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz