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临床试验/NCT00204932
NCT00204932已完成2 期

Effects of CLA Supplements on Body Weight and Fat Oxidation

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Fat Mass

研究概览

简要总结

Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.

详细描述

Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing [1-13C]oleate and D31-palmitate into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25-29.9 kg/m2
  • Absence of a weight change of greater than 3 kg in the previous 6 months

排除标准

  • Presence of a physical limitation to walking exercise
  • Current or recent (6 months) enrollment in a commercial or self-prescribed weight loss program
  • A history of metabolic disease-ie. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
  • A history of a psychiatric or eating disorders Ÿ Presence of metal implants that would interfere with body composition analysis
  • Fasting plasma cholesterol >300mg/dl or triglycerides above 500 mg/dl.
  • Abnormal EKG

研究组 & 干预措施

CLA treatment

Active Comparator

The group randomized to Conjugated Linoleic Acid (CLA) treatment at 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA; and 22% safflower oil for 6 months

干预措施: conjugated linoleic acid (Drug)

Placebo

Placebo Comparator

The group randomized to control received 4 g/d of safflower oil.

干预措施: conjugated linoleic acid (Drug)

结局指标

主要结局

Fat Mass

时间窗: 6 months

loss of fat mass, kg

次要结局

  • Total Fat Oxidation(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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