NCT06193577招募中不适用
Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
详细描述
Monocentric, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract (test) on weight reduction and on metabolic parameters after 12 weeks of supplementation. The efficacy on weight reduction will be evaluated in comparison with the placebo group (control).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged between 18 and 60 years
- •BMI between 25 and 35 kg/m2
- •Habitual consumption of three main meals a day
- •Stable body weight during the 3 months prior to enrollment
- •Commitment to adhere to the diet and avoid the use of other weight loss products during the study
- •Commitment not to change lifestyle significantly for the entire duration of the study.
- •Signing of informed consent
排除标准
- •Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism
- •Diabetes mellitus
- •Smoking > 10 cigarettes/day
- •Alcohol > 2 alcohol units/day (equal to 24 g of ethanol)
- •History of eating disorders during the 12 months prior to enrollment
- •Use of any drug or product to treat obesity (e.g. meal replacements)
- •Presence of acute or chronic gastrointestinal diseases
- •Active use of drugs that could influence the functions: gastrointestinal (e.g. laxatives, etc.), insulin (insulin sensitizers, etc.) and/or testicular (hormones, substances that influece testosterone production
- •Known sensitivity to the ingredients of the preparation
- •Any other clinical condition judged by the investigator to be incompatible with participation in the trial
结局指标
主要结局
Change in weight
时间窗: 0, 12 weeks
Weight evaluation before and after treatment
次要结局
- Change in glycemia(0, 4, 8, 12, 18 weeks)
- Change in insulin levels(0, 4, 8, 12, 18 weeks)
- Change in weight(0, 4, 8, 18 weeks)
- Change in carboxylated osteocalcin (cxOCN) levels(0, 4, 8, 12, 18 weeks)
- Change in LH levels(0, 4, 8, 12, 18 weeks)
- Change in FSH levels(0, 4, 8, 12, 18 weeks)
- Change in SHBG levels(0, 4, 8, 12, 18 weeks)
- Change in uncarboxylated osteocalcin (ucOCN) levels(0, 4, 8, 12, 18 weeks)
- Change in calculated free testosterone (CFT) concentrations(0, 4, 8, 12, 18 weeks)
- Sperm count(0, 12, 18 weeks)
- Change in Body Mass Index(0, 4, 8, 12, 18 weeks)
- Change in albumin levels(0, 4, 8, 12, 18 weeks)
- Sperm motility(0, 12, 18 weeks)
- Tunel test(0, 12, 18 weeks)
- Change in total testosterone levels(0, 4, 8, 12, 18 weeks)
- Change in 17-beta-estradiol levels(0, 4, 8, 12, 18 weeks)
- Sperm morphology evaluation(0, 12, 18 weeks)
- Sperm vitality(0, 12, 18 weeks)
研究者
研究点 (2)
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