Intestinal Microbiota: Immunity, Recovery and Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Concentrations of inflammatory markers from the blood samples
研究概览
简要总结
The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults.
详细描述
The study is a randomized, double-blind, 3-arm intervention involving young adults (n=160). Participants are randomized into three groups to receive different study product, and differences among the groups will be compared, for example, in terms of gut microbiota, weight changes, and inflammatory markers derived from blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 17 Years 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •medicines and diseases that significantly affect the functioning of the stomach and intestines (e.g. irritable bowel syndrome)
- •antibiotic treatment within 3 months
- •asthma medication
- •milk allergy (protein); the study product is lactose-free
- •the participant must adhere to avoid the use of foods or nutritional supplements containing probiotics, and high-protein products, e.g. whey protein powders and high-protein snack bars
结局指标
主要结局
Concentrations of inflammatory markers from the blood samples
时间窗: At the baseline (week 0) and after eight weeks (last visit)
hs-CRP (High-Sensitivity C-Reactive Protein), haptoglobin, suPAR (soluble urokinase-type Plasminogen Activator Receptor)
次要结局
- Waist circumference of the participant(At the baseline (week 0) and after eight weeks (last visit))
- Development of physical fitness(At the baseline (week 0) and after eight weeks (last visit))
- Changes in recovery(During intervention (Eight weeks))
- Blood pressure(At the baseline (week 0), at four weeks and after eight weeks (last visit))
- Infections during the intervention(During intervention (Eight weeks))
- Changes in the sleep quality(During intervention (Eight weeks))
- Changes in the gut microbiota composition, diversity and function(At the baseline (week 0) and after eight weeks (last visit))
- Weight of the participant(At the baseline (week 0), at four weeks and after eight weeks (last visit))
- BMI(At the baseline (week 0), at four weeks and after eight weeks (last visit))
研究者
Kirsi Laitinen
Professor
University of Turku