None listed
Conditions
Interventions
Intervention1: LI85008F: Dose: 2 capsules (each capsule containing 450 mg of novel botanical formulation (LI85008F),Frequency: BD Duration: 112 Days Route of Administration: Oral
Control Intervention1
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female subjects between 21 to 50 years of age • Subject with BMI range (27-29.9) • Ability to understand the risks/benefits of the protocol • 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. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. • Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) during the course of the study. • Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 1800 kcal/day (approximately 17% protein, 25% Fat and 58% carbohydrate). • Subject should be available for duration of study period (6-8 months) • Subject agrees to come to site in fasting state for their weight measurement and other laboratory parameters examination at all the scheduled visits. • Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue those therapies during this study. • Subject agrees not to start any new therapies for weight loss during the course of the study. • Subjects willing to go for DEXA analysis during the course of study. • Subjects agree to maintain the activity dairy • Willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: •Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain two months prior to screening. • Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget disease, joint fracture, acromegaly, fibromyalgia, Wilson disease, ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis. • Subjects having history of asthma • Subjects having history of cardiovascular diseases • Subjects having history of diabetes (Type I or Type II) - except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose between 140-199 mg/dl. • Subject with Hyperuricaemia (males > 480 µmol/L, females > 450 µmol/L). • Subjects having thyroid diseases. • Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal, elevated Creatinine, males > 125 µmol/L, females > 110 µmol/L). • Subjects having abnormal findings on complete blood count. • Subjects having history of coagulopathies. • Subjects with hypertension. • Subjects with HIV Positive. • Subjects having history of congestive heart failure. • Subjects having history of high alcohol intake ( >2 standard drinks per day). • Pregnant, breast feeding or planning to become pregnant during the study. • Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. • Any other condition that, in the opinion of the investigator, would adversely affect the ability of subjects to complete the study or its measures. • Subjects participated in any investigational study medication within thirty (30) days prior to screening. • Use of any weight loss medications or any supplements, programs, or meal replacement products intended to alter body weight within two months prior to screening or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Body weightTimepoint: Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change from the baseline to the end of the treatment period in : o Reduction of BMI o Change in Waist Hip ratio o Reduction in body fat and improvement in Lean body mass (Body-fat composition analysis by DEXA o HDL, LDL, VLDL, Total cholesterol and Triglyceride (TGL) â?¢ Endpoints for Safety o Tolerability and acceptance as recorded in the subject daily diary &compliance card. o Adverse events (AEs), frequency and severity. â?¢ Changes in the vital parametersTimepoint: Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 | — |
Countries
India
Contacts
Public ContactShekhar Gupta
Laila Nutraceuticals
Outcome results
None listed