Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
研究概览
简要总结
Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.
详细描述
Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed 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
- Crossover
- 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
- •Age 18-65 years.
- •Both genders.
- •BMI 25-34.9 kg / m2, both inclusive.
- •Weight maintained during the last 3 months.
- •Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
- •Absence of disease diagnosed at the start of the study.
排除标准
- •Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
- •Participation in another clinical trial in the three months prior to the study.
- •Lack of will or inability to comply with clinical trial procedures.
- •Pregnant woman.
- •Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
结局指标
主要结局
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Evolution of appetite sensation
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Appetite sensation at 240 minutes post-ingestion and area under the curve of the evolution of appetite feeling from instant zero post-intake to instant 240 minutes post-intake
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Appetite feeling immediately after ad-libitum food
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Sensation of appetite before intaking the product under investigation
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Average of the appetite sensation during the 60 minutes after intake of the experimented product
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Amount of energy consumed during the ad-libitum meal
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Satiety quotient (SQ)
时间窗: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
次要结局
- Ghrelin (GHRL)(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Adiponectin(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- HDL - Cholesterol(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Insulinemia(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Leptin(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Glucagon Like Peptide - 1 (GLP-1)(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Liver safety variables(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Blood glucose(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Physical activity(It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Gastrointestinal Quality of Life Test(It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Tyrosine Peptide Tyrosine (PYY)(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.)
- Peripheral insulin resistance (HOMA-IR)(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- LDL - Cholesterol(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Triglycerides(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Body mass index(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Glycosylated hemoglobin (HBA1c)(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Total Cholesterol(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Fat mass(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Muscle mass(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Quality of Life Test(It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia