None listed
Conditions
Interventions
Intervention1: Study drug: 250mg x 2capsules (total 500mg) once daily for a period of 8 weeks.
Control Intervention1: Placebo: 250mg x 2capsules (total 500mg) once daily for a period of 8 weeks.
Sponsors
Plantlipids P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or Female, age between 18years to 50years 2. BMI between 18 and 29 kg/m2 3. Female participant is not of childbearing potential or Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 4. Good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician 5. Willing to maintain current exercise and dietary regimen as well willing to collect faecal samples during the study. 6. May need to exclude or limit turmeric and asafoetida as spices or supplements from the diet for the duration of the study to minimize confounding factors. 7. Has normal results from their blood work (CBC with differential, lipid panel, and fasting glucose) and, stool (occult blood and pH) and urine analysis prior to enrolment. 8. Has given voluntary, written, and dated informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breastfeeding or planning to become pregnant 2. Daily use of supplements that contain probiotics, prebiotics, or synbiotics within the 30 days prior to screening or during the study 3. Daily consumption of foods containing significant amounts of sugar alcohols such as xylitol, mannitol, maltitol, sorbitol, and mannitol ( >20g/d). Examples include sugar-free or reduced-sugar protein bars. 4. Acute infection requiring systemic antibiotic or antiviral therapy or use of antibiotics (within the 30 days prior to screening). 5. Regular use of anti-inflammatory medication, including 81 mg aspirin, (more than once per week), or if prescribed by a physician. 6. Diarrheal illness (within the 30 days prior to screening) 7. Current anemia or Iron supplements 8. Rectal bleeding or â??frank bloodâ?? or occult in the feces or clinically significant abnormal results from routine fecal analysis 9. Allergy or sensitivity to study supplement ingredients 10. Use of illicit drugs or drug abuse within the last year 11. Currently consume greater than 2 standard alcoholic drinks per day or has a history of alcohol abuse within the past 5 years 12. Currently active smokers (tobacco products, and e-cigarettes) or smoking within the 6 months of enrollment 13. Previously or currently diagnosed with an eating disorder 14. Current, or previous history of gastrointestinal disorders (e.g. IBS, gastric ulcers, Crohnâ??s disease or Colitis) 15. Type 1 and Type 2 Diabetes Mellitus and individuals on diabetic medications 16. Current, or history of within last 5 years, renal disease 17. Current, or history of within last 5 years, hepatic disease 18. Immunocompromised individuals such as those that have undergone organ transplantation, those with rheumatoid arthritis, or subjects diagnosed with human immunodeficiency virus (HIV), AIDS, or hepatitis 19. Medical history of or current thyroid disease 20. Cancer, except skin cancers, completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 21. Currently diagnosed with, or history of, cardiovascular disease 22. Current, or history of, bleeding disorders 23. Uncontrolled hypertension (systolic blood pressure >=150 mmHg or diastolic >90 mmHg) 24. Current, or historical diagnosis of, or individuals on medication for, a sleep disorder, clinical depression, or anxiety by verbal communication and as assessed by the qualified investigator 25. Anti-psychotic medication, or with a history of psychiatric disorder by verbal communication and as assessed by the qualified investigator 26. Participation in a clinical research trial within 30 days of enrolment 27. Clinically significant abnormal laboratory results at screening 28. Any medical condition or use of any medication, nutritional product, dietary supplement, or program which, in the opinion of the investigator, might interfere with the results or conduct of the study or place the subject at risk. 29. Any other condition which in the qualified investigatorâ??s opinion may adversely affect the individualâ??s ability to complete the study or its measures or which may pose significant risk to the individual.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in haematological parameters as compared on Day 0 and Day 60. 2.Change in lipid profile as compared on Day 0 and Day 60. 3.Change in feacal microbiota CFUs as compared on Day 0 and Day 60. 4.Change in immunological marker as compared on Day 0 and Day 60. Timepoint: 1.Change in haematological parameters as compared on Day 0 and Day 60. 2.Change in lipid profile as compared on Day 0 and Day 60. 3.Change in feacal microbiota CFUs as compared on Day 0 and Day 60. 4.Change in immunological marker as compared on Day 0 and Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Quality of life questionnaires as assessed by Gastrointestinal Symptoms Rating Scale (GSRS) at different study time points (Day 1 and Day 60) 2.Change in Stool frequency as assessed by average of the bowel habits diary by by Bristol Stool Form Scale (BSS) ( Day 1 and 60) Timepoint: Screening Visit:Day -3 to Day 0,Baseline visit:Day 1,Week 4(Day 30),End of the visit Week 8 (Day 60) | — |
Countries
India
Contacts
Public ContactDivya C
Bio Agile Therapeutics Private Limited
Outcome results
None listed