None listed
Conditions
Interventions
Intervention1: CL16049F1 300 mg/Day: One capsule to be taken daily after dinner for 12 weeks
Control Intervention1: Active Comparator 320 mg/Day: One capsule to be taken daily after dinner for 12 week
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ambulatory, male and female subjects 25â??60 years of age with a Body Mass Index (BMI) between 23.0 and 29.0 kg/m2. 2.Subjects with Fatty Liver Index between 31 and 59. 3.Subjects with no pre-existing medical conditions. 4.Subjects with fasting blood glucose levels 5.Results upon screening Clinical lab observations should be within normal range or considered not clinically significant by the principal investigator. 6.Subjects not currently taking medicines or supplements for liver health. 7.Subjects who are non-alcoholic and non-smokers. 8.Subject agrees to maintain diet tracker. 9.Willing to sign the informed consent and to comply with study procedures. 10.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
Exclusion criteria
Exclusion criteria: 1.Subjects with hepatic abnormalities confirmed by ultrasound scan. 2.Subjects having Allergy or hypersensitivity to any of the ingredients in the investigational products. 3.Subjects with gastrointestinal diseases such as Crohns disease or gastrointestinal surgery. 4.Subjects with hepatitis or autoimmune liver diseases. 5.History of Esophageal varices, viral hepatitis, hepatic encephalopathy, ascites (past 12 months). 6.Subject having history of cirrhosis or liver cancer. 7.History of underlying biliary diseases such as jaundice or gallstones. 8.History of underlying kidney disease such as chronic renal failure or nephrotic syndrome. 9.Subjects who are diabetic, or under medication of any chronic disease including hyperlipidemia, hypertension. 10.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, thyroid dysfunction. 11.Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period. 12.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 13.Subjects currently participating or participated in any other clinical trials within 60 days prior to the Screening visit. 14.Subjects not willing to discontinue use of dietary supplements containing vitamins, minerals, herbal or plant-based preparations, fish oil or homeopathic remedies during study participation. 15.Subjects with HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement from baseline to end of the trial period in â?¢Fatty liver index (FLI)Timepoint: Screening, Week 1 (baseline), Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement from baseline to end of the trial period in: â?¢HOMA â??Insulin Resistance â?¢Serum biomarker analysis for oxidative stress in liver health {(Malondialdehyde (MDA), Superoxide dismutase (SOD), Glutathione (GSH), Catalase, Thiobarbituric acid reactive substances (TBARS) and 8-hydroxydeoxyguanosine (8-OHdG)} â?¢Cystatin C levelTimepoint: Week 1(baseline) and Week 12;Improvement from baseline to end of the trial period in: â?¢Liver function tests â?¢Serum lipid profile â?¢Gastrointestinal symptoms questionnaire â?¢Well-being (quality of life) questionnaireTimepoint: Screening, Week 1(baseline), Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed