NCT05758363已完成不适用
Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Universidad Católica San Antonio de Murcia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of weight loss
研究概览
简要总结
The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.
详细描述
The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (age: 30 - 70 YO)
- •BMI over 25 kg/m
- •Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.
排除标准
- •Subjects with eating disorders.
- •BMI less than 25 Kg/m
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Participation in another clinical trial in the three months prior to the study.
- •Unwillingness or inability to comply with clinical trial procedures.
- •Pregnant woman.
- •Participants with an active daily exercise activity.
- •Subjects whose condition makes them ineligible for the study at the investigator's discretion.
结局指标
主要结局
Evaluation of weight loss
时间窗: From baseline to 6 months later
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.
次要结局
- Dietary intake(From baseline to 6 months later)
- Quality of life by WHOQOL-BREF(From baseline to 6 months later)
- Quality of life by SF-36(From baseline to 6 months later)
- Depression(From baseline to 6 months later)
- Anxiety(From baseline to 6 months later)
- Stress(From baseline to 6 months later)
研究者
Desirée Victoria Montesinos
Principal Investigator
Universidad Católica San Antonio de Murcia
研究点 (2)
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