Clinical study of nutritional supplement Supply6 360 to improve gut health.
- Registration Number
- CTRI/2024/03/063507
- Lead Sponsor
- Kanari Nutrition Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy male and females between 25-35 years of age both inclusive. 2.BMI between 18.5 – 29.9 kg/m2. 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the Gastrointestinal Symptom Rating Scale (GSRS) scoreTimepoint: From screening visit to end of the study
- Secondary Outcome Measures
Name Time Method 1.Changes in lipid profile. <br/ ><br>2.Changes in serum vitamin B12 and vitamin D3 levels. <br/ ><br>3.Changes in fatigue severity score. <br/ ><br>4.Changes in the levels of NAD+ (by ELISA) as an indicator of energy. <br/ ><br>5.Percent responders to a reduction in requirement of rescue medication for gastric symptoms (at least 50% reduction in doses or medication events in a month). <br/ ><br>6.Gut microbiota assessment.Timepoint: From screening visit to end of the study