Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioithas SL
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Changes in body weight between baseline and 6- and 12-weeks
研究概览
简要总结
The study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years.
Overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common.
The objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type I obesity (BMI 25 - 34.9 kg/m2).
This randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo).
In this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥ 18 years.
- •Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I).
- •Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study.
- •Signing of informed consent.
排除标准
- •Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain.
- •Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study.
- •Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months.
- •Treatment with antibiotics in the previous 4 weeks.
- •Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks.
- •Consumption of products containing probiotics in the previous 2 months.
- •Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients.
- •In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.
研究组 & 干预措施
PLACEBO
干预措施: Placebo (Dietary Supplement)
PROBIOTIC
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in body weight between baseline and 6- and 12-weeks
时间窗: Baseline, 6-week and 12-week
Changes in body mass index (BMI) baseline and 6- and 12-weeks
时间窗: Baseline, 6-week and 12-week
次要结局
- Changes in leptin levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks(Baseline, 6-week and 12-week)
- Changes in body composition between baseline and 12-weeks(Baseline and 12-week)
- Changes in blood pressure between baseline and 6- and 12-weeks(Baseline, 6-week and 12-week)
- Changes in gut microbiota composition between baseline and 12-weeks(Baseline and 12-week)
- Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks(Baseline, 6-week and 12-week)
- Changes in the score of International Physical Activity Questionnaire (IPAQ) between baseline and 12-weeks(Baseline and 12-week)
- Changes in the MEDiterranean LIFEstyle index (MEDLIFE) questionnaire between baseline and 12-weeks(Baseline and 12-week)
- Changes in the score of the Simplified Nutritional Appetite Questionnaire (SNAQ) between baseline and 12-weeks(Baseline and 12-week)
- Changes in blood count between baseline and 12-weeks(Baseline and 12-week)
- Changes in glucose levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in insulin levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in LDL and HDL, and total cholesterol levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in triglycerides levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in creatinine and urea levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks(Baseline and 12-week)
- Changes in C-reactive protein levels between baseline and 12-weeks(Baseline and 12-week)