Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in count of regulatory T-cells from baseline to week 4
研究概览
简要总结
Pro-Health is a single-center, double-blind, randomized and placebo-controlled intervention study in healthy adults. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in healhty adults.
详细描述
Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Patients with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to increase the PA serum levels by oral PA food supplementation in healthy adults in order to perspectively intervene with the same strategy in patients with CKD in the near future, with the target to increase abundance and function of antiinflammatory cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 40 years old
- •Body weight: > 30kg
排除标准
- •Disease or dysfunctions, which disqualifies the patient
- •Incapacity of contract or any other circumstances, which prohibit the patient from understanding setup, meaning and entity of the study
- •Acute infections
- •Immunosuppressive therapy within the last 12 weeks before the start of the study
- •Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study
- •Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study
- •Malignant diseases
- •Pregnancy
- •chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease
- •alcohol- or drug abuse
- •parallel participation on other interventional trials
研究组 & 干预措施
Placebo Intervention
The control-group receives a placebo instead of propionate. The placebo contains maltodextrin and the same amount of sodium chloride as compared to the PA intervention. The placebo is taken twice per day for 28 days.
干预措施: Placebo (Other)
PA Intervention.
The group which receives the PA as a dietary food supplement. A single capsule contains 500mg of sodiumpropionate, which is taken twice daily for 28 days.
干预措施: Sodium propionate (Dietary Supplement)
结局指标
主要结局
Change in count of regulatory T-cells from baseline to week 4
时间窗: Baseline visit (week 0) in comparison to week 4
Analysis of Treg counts in whole blood (absolute quantification) and peripheral blood
次要结局
- Cholesterol levels(Baseline visit (week 0); Week 2; Week 4)
- Propionic acid serum levels and targeted metabolomics(Baseline visit (week 0); Week 2; Week 4)
- Relative abundance of different immune cell subsets with Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)(Baseline visit (week 0); Week 2; Week 4)
- Measuring the suppressive function of regulatory T cells (Tregs) as percentage of proliferated conventional CD4-positive T cells with an in vitro T regulatory cell (Treg) suppression assay(Baseline visit (week 0); Week 4)
- Taxonomy of the fecal microbiome(Baseline visit (week 0); Week 4)
- Cardiovascular Phenotyping(Baseline visit (week 0); Week 2; Week 4)
- Cardiovascular Phenothyping(Baseline visit (week 0); Week 2; Week 4)
- Single cell RNA sequencing of immune cells(Baseline visit (week 0); Week 4)
- Measuring the intestinal barrier function by measuring the concentration of different leaky gut markers(Baseline visit (week 0); Week 2; Week 4)
研究者
Johannes Benjamin Holle
Principal Investigator
Charite University, Berlin, Germany