NCT04105192已完成不适用
Randomized Controlled Clinical Trial on the Efficacy of a Natural Ingredient in Obesity in Subjects With a BMI Greater Than 25 kg / cm2
Universidad Católica San Antonio de Murcia2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年3月1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
- 84
- 试验地点
- 2
- 主要终点
- Fat mass in lower limbs
研究概览
简要总结
randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.
详细描述
The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes with age between 18-65 years.
- •Subjects with a body mass index greater than 25 and less than
- •Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.
排除标准
- •Subjects under treatment that may affect body weight.
- •Subjects with acute diseases.
- •Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease.
- •Subjects undergoing major surgery in the last 3 months.
- •Subjects who quit smoking in the last 6 months or who intend to quit during the study.
- •Subjects with allergies or eating disorders.
- •Volunteers who are participating in another study that includes blood draws or dietary intervention.
- •Pregnant or breastfeeding woman.
- •Subjects whose condition does not make them eligible for the study, according to the researcher.
结局指标
主要结局
Fat mass in lower limbs
时间窗: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Total fat mass
时间窗: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in torso
时间窗: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
次要结局
- blood samples: Glucidal metabolism and lipid metabolism.(Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.)
- Muscle mass(Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.)
- physical activity(Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study)
- Fat mass(Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.)
- Percentage of fat mass(Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.)
- Subjective sensation of product consumption(Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.)
- Height(Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).)
- liver safety variables(Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group.)
- Weight(Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
研究点 (2)
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