Evaluation of the Safety and Tolerance of a New Fermented Food in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Effect of 1 bottle/day of test versus control product on kidney function.
研究概览
简要总结
The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects after receiving a full description of the study, provide written informed consent to take part in the study.
- •Free-living subject, as evaluated during the clinical examination.
- •Male/female subjects aged between 18 to 55 years (bounds included).
- •Subjects with a body mass index (BMI) between 18.5 ≤ BMI < 30kg/m².
- •Healthy subjects (as determined by a medical examination)
排除标准
- •Subjects with any allergy (food, respiratory...).
- •Subjects that have had any surgery or intervention requiring general anaesthesia in the last 4 weeks.
- •Subjects with a history of chronic metabolic or gastrointestinal disease with the exception of appendectomy.
- •Subjects with chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV).
- •Subjects presenting a severe evolutive or chronic pathology (e.g. cancer,tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis, Type I diabetes...).
- •Subject with eating disorders.
- •Subjects with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever.
- •Subjects with special medicated diet (for obesity, anorexia, metabolic pathology...).
- •For female subjects: pregnancy, breast-feeding or not willing to use/not using an acceptable method of contraception
- •Subject, in the Investigator's opinion, should not be randomised.
结局指标
主要结局
Effect of 1 bottle/day of test versus control product on kidney function.
时间窗: During the 4-week period of product consumption.
Blood creatinin (μmol/L).
Effect of 1 bottle/day of test versus control product on blood marker of inflammation.
时间窗: During the 4-week period of product consumption.
Blood C-reactive protein (mmol/L)
Effect of 1 bottle/day of test versus control product on bowel habits.
时间窗: During the 4-week period of product consumption.
Stool frequency and consistency (Bristol Stool Scale from 1 \[hard stools\] to 7 \[watery stools\]).
Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.
时间窗: During the 4-week period of product consumption.
blood glucose (mmol/L), lipids \[total cholesterol, HDL, LDL, triglycerides\] (mmol/L).
Effect of 1 bottle/day of test versus control product on liver function.
时间窗: During the 4-week period of product consumption.
Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).
Effect of 1 bottle/day of test versus control product on digestive symptoms.
时间窗: During the 4-week period of product consumption.
Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.
Effect of 1 bottle/day of test versus control product on adverse events.
时间窗: During the 4-week period of product consumption.
Number of Adverse events, number of AE related to product, number of emergent AE, number of mild/moderate and severe AE, number of serious AE.
Effect of 1 bottle/day of test versus control product on thyroid function.
时间窗: During the 4-week period of product consumption.
Blood thyroid stimulating hormone (mU/L).
Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.
时间窗: During the 4-week period of product consumption.
Fecal calprotectin (μg/g)
Effect of 1 bottle/day of test versus control product vital signs.
时间窗: During the 4-week period of product consumption.
Systolic/diastolic blood pressure (mmHg).
Effect of 1 bottle/day of test versus control product on hematology.
时间窗: During the 4-week period of product consumption.
Hemoglobin (mmol/L).
次要结局
- Effect of 1 bottle/day of test versus control product on liver function.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on kidney function.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on blood marker of inflammation.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on bowel habits.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on adverse events.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on digestive symptoms.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on kidney function.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on thyroid function.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on thyroid function.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on liver function.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on fecal marker of inflammation.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on test product strains detection and quantification in feces.(During the 4-week period of product consumption and after 4-week follow-up period.)
- Effect of 3 bottles/day of test versus control product on test product strains detection and quantification in feces.(During the 4-week period of product consumption and after 4-week follow-up period.)
- Effect of 3 bottles/day of test versus control product on blood marker of inflammation.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on adverse events.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on bowel habits.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on digestive symptoms.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on glucose and lipids metabolism.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on microbiota analysis in feces.(During the 4-week period of product consumption and after 4-week follow-up period.)
- Effect of 1 bottle/day of test versus control product vital signs.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on hematology.(During the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product vital signs.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 3 bottles/day of test versus control product on hematology.(During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.)
- Effect of 1 bottle/day of test versus control product on microbiota analysis in feces.(During the 4-week period of product consumption and after 4-week follow-up period.)