A pilot clinical study to evaluate the safety and effectiveness of nutritional supplement Supply6 360 in improving gastrointestinal health and wellness.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in the Gastrointestinal Symptom Rating Scale (GSRS) score
研究概览
简要总结
The study of human gut microbiota has significantly expanded in recent years. The gut microbiota exerts an impact on the host’s metabolism, physiology, and the development of the immune system. The gut microbiota composition is influenced by various factors, including nutrition, age, host genetics, medicines, and lifestyle. Changes in the makeup and operation of the gut microbiota have a direct impact on human well-being and are crucial in the development of various diseases. In today’s fast-paced and modern world, people often find it challenging to engage in physical activity due to sedentary desk occupations. This lifestyle, paired with difficulties in accessing healthy meals, contributes to the ingestion of unhealthy (junk) food. As a result, these individuals may encounter gastrointestinal symptoms, such as pain in the upper abdomen, discomfort in the abdominal area, heartburn, nausea and bloating etc. In order to address this problem, a formulation that is enhanced with vitamins, minerals, and bioactive substances and intended to improve gastrointestinal health is needed. The current clinical trial aims to establish empirical evidence about the safety and efficacy of the Supply 6 360 sachet, which is formulated by virtue of the selection of ingredients, in treating gastrointestinal problems in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and females between 25-35 years of age both inclusive.
- •2.BMI between 18.5 – 29.9 kg/m
- •3.Subjects should self-report at least two of the following gastrointestinal symptoms: epigastric discomfort, heartburn, bloating, nausea, fullness in the stomach, abdominal pain, or anorexia.
- •4.Not consuming probiotics, prebiotics, etc.
- •5.Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
排除标准
- •1.Participants with major abdominal surgery a history of inflammatory bowel disease or diverticular disease celiac disease allergic diseases including asthma psychiatric disorders and critical systemic illness as assessed by medical history appropriate consultations and laboratory tests 2.Actively having a gut infection 3.History of or complications from malignant tumors 4.Females who are pregnant and have a positive urine pregnancy test planning to be pregnant/lactating or not using reliable methods of contraception 5.Participants with heavy alcohol consumption or smoking or tobacco consumption 6.Any condition that could in the opinion of the investigator preclude the participants ability to complete the study or that may confound study outcomes.
结局指标
主要结局
Changes in the Gastrointestinal Symptom Rating Scale (GSRS) score
时间窗: From screening visit to end of the study
次要结局
- 1.Changes in lipid profile.(2.Changes in serum vitamin B12 and vitamin D3 levels.)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre