None listed
Conditions
Interventions
Intervention1: CL19183: 450 mg per day, One capsule daily in the morning after breakfast for 16 weeks
Control Intervention1: Placebo: One capsule daily in the morning after breakfast for 16 weeks
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects aged between 25-55 years with body mass index (BMI) of 25 - 29.9 kg per metre square. 2.Subjects with sedentary lifestyle, no regular athletic or sports activities. 3.Subjects willing to participate in walking-exercise (5 days a week, 30 min per day) over study duration. 4.Subjects with normal thyroid hormone profile. 5.Subjects agreed to consume recommended standard diet. 6.Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks & chocolate for at least 24 hrs. prior to visits and final visit. 7.Subjects who are non-smokers. 8.Subject agrees to maintain diet tracker. 9.Subject considered generally healthy as per health history and routine clinical investigations during screening. 10.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit. 11.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants, beta-blockers, hormones, etc.). 2.Subjects on weight loss practices, usage of weight reduction supplements/nutrition products will be excluded. 3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded. 4.Subjects participated in any weight loss programs within 3 months. 5.Subjects who are diabetic and/or hypertensive. 6.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. 7.Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer). 8.Subjects with HIV Positive. 9.Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study. 10.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 11.Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures. 12.Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and caffeinated and not caffeinated thermogenics within 30 days prior to the study. 13.Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Body weightTimepoint: Day 1 (baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Respiratory Exchange Ratio (RER)Timepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in Resting metabolic rate (RMR)Timepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in blood biomarkers UCP -1 & PGC-1 Alpha mRNATimepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in Body composition & BMI (using DEXA scan)Timepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in HOMA-IRTimepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in Lipid profileTimepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in POMS (SF) questionnaireTimepoint: Day 1 (baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in serum biomarkers Adiponectin, ghrelin & glucagon-like peptide 1(GLP-1)Timepoint: Day 1 (baseline), Week 8 & Week 16;Change from baseline to the end of the study period in Waist circumference (WC)Timepoint: Day 1 (baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in Waist to hip ratio (WHR)Timepoint: Day 1 (baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed