Nutritional Intervention Study to Evaluate the Effect of a Symbiotic Drink on the Microbiota and Different Nutritional Markers in Healthy Volunteers
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
- 1
- 主要终点
- Relative abundance of the gut microbial species
研究概览
简要总结
This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group (which will consume the fermented drink) and a control group, which will consume a drink with similar characteristics, but without the presence of bioactive components.
详细描述
At the beginning of the trial, you will have an interview (screening visit) with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it. If it is confirmed that you meet the criteria to participate in the study, after your assent and informed consent have been obtained, you will be able to do so. At the first visit, you will be assigned a code by a random method (computerized) and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The study will be masked by using identical packaging for both the study group and the control group (placebo), which participants will consume at home or at their mealtimes during the 6 weeks of the intervention.
The researchers themselves will administer the product (with identical external appearance for both groups) individually to each participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 18 years of age.
- •Caucasian ethnicity
- •Adequate level of culture and understanding of the clinical study.
- •Agree to voluntarily participate in the study and give written informed consent.
排除标准
- •Subjects with dementia, mental illness or decreased cognitive function that prevents the study from being carried out.
- •Subjects with serious diseases (liver, kidney, immunosuppressed, etc.).
- •BMI ≥ 30 kg/m2, pregnant or breastfeeding women.
- •Presence of immunological pathologies, gallstones, gastric ulcer or coagulation problems.
- •Presence of any other specific pathology that contraindicates the intake of dietary supplements, specifically inulin and probiotics (diverticulitis, etc.).
- •Subjects who are undergoing antibiotic treatment or consuming probiotic supplements.
- •Subjects who are undergoing pharmacological treatment for weight loss.
- •Subjects who refuse to follow the guidelines for healthy eating or the consumption of the study drink in the indicated guidelines.
- •Any other exclusion criteria that the principal investigator of the study considers relevant.
- •Non-Caucasian ethnicity
研究组 & 干预措施
Study Group
Participants will consume a 250cl bottle of soluble fibre-enriched kombucha mid-morning or mid-afternoon, avoiding consumption after eating. The drink will be included in a healthy eating plan. They will be advised to continue their usual physical activity during the 6 weeks of the study.
干预措施: Kombucha tea (Dietary Supplement)
Control Group
Participants will consume one 250cl bottle of a similar unfermented and unfortified beverage mid-morning or mid-afternoon, avoiding consumption after eating. The beverage will be included in a healthy eating plan. Participants will be advised to continue their usual physical activity for the 6 weeks of the study.
干预措施: Kombucha tea (Dietary Supplement)
结局指标
主要结局
Relative abundance of the gut microbial species
时间窗: 6 weeks
Analyze the variations in the relative abundance of the microbial species present, including taxonomic identification, diversity analysis, and phylogenetic composition.
次要结局
未报告次要终点
研究者
María Isabel Espinosa
Principal Investigator
IMDEA Food