Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
A total 60 human subjects will be randomised and divided into three groups:
1. LI-12508
2. LI-12507F
3. Placebo
The treatment dosage is 800 mg daily, consisting of two 400 mg doses daily for the acti
Sponsors
Laila Nutraceuticals (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must understand the risks and benefits of the study 2. Adults ages 21 - 50 years, either sex 3. Body mass index (BMI) less than 30 kg/m^2 4. Willingness to participate in an exercise-walking program, supervised by a trained exercise specialist 5. Willingness to consume the prescribed study diet of approximately 2,000 K Cal per day as outlined in the protocol (meals will be provided at free of cost by the study sponsor) 6. Ability to provide written informed consent for participation in the trial 7. Willingness to complete standard health history questionnaire before induction into the study 8. Willingness to participate in five clinic visits (Screening, baseline, 2, 4 and 8 weeks) 9. Subject willing to participate in health exercise program (30 minutes walking) monitored by the study physical trainer 10. Subjects must be instructed to abstain from alcoholic products during the study 11. If female, patients: 11.1. Should be negative in pregnancy test 11.2. Should not be nursing 11.3. If of childbearing potential, should agree to follow an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), etc., or post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Exclusion criteria
Exclusion criteria: 1. History of thyroid disease or cardiovascular disease or diabetes (uncontrolled) 2. Subjects having chronic diarrhoeal disorders, cancer, neurological disorders, hepatic dysfunction 3. Respiratory tract infection and other serious medical respiratory illnesses (i.e., chronic obstructive pulmonary disease [COPD], sarcoidosis) 4. History of allergy to spices and herbal products 5. Intractable obesity or uncontrolled body weight, BMI greater than 40 kg/m^2 6. Non-obese (BMI less than 30 kg/m^2) and morbidly obese (BMI greater than 40 kg/m^2) 7. Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss 8. Pregnant or nursing or lactating females 9. Recent, unexplained weight loss or gain 10. Women with a positive pregnancy test 11. Human immunodeficiency virus (HIV) or other known immunodeficiency 12. Undergone surgery before 30 days of screening or planning to undergo surgery within the study days 13. History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis 14. History of motor weakness or peripheral sensory neuropathy 15. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical/anthropometric parameters: 1.1. Body weight 1.2. Body mass index 1.3. Waist hip ratio 2. Biochemical parameters (serum/plasma): 2.1. Fasting glucose 2.2. Fasting insulin 2.3. Triglyceride 2.4. Cholesterol 2.5. High density lipoprotein (HDL) cholesterol 2.6. Low density lipoprotein (LDL) cholesterol The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Obesity biomarkers (serum/plasma): 1. Leptin 2. Adiponectin 3. Ghrelin The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. | — |
Countries
India
Outcome results
None listed