Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
A total of 100 human subjects is randomised and divided into four groups:
1. Adipolean
2. Adipolite
3. Betelean
4. Placebo
The treatment dosage is 1500 mg day, consisting of three 500 mg doses dail
Sponsors
Laila Nutraceuticals (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 21 - 50 years 2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2 3. Willingness to participate in an exercise-walking program, supervised by a trained exercise specialist 4. Willingness to consume the prescribed study diet of approximately 2,000 KCal per day as outlined in the protocol (meals will be provided at free of cost by the study sponsor) 5. Written informed consent to participate in the trial 6. Willingness to complete standard health history questionnaire before induction into the study 7. Willingness to participate in five clinic visits (screening, baseline, 2, 4 & 8 weeks) 8. If female: 8.1. Should be negative in pregnancy test 8.2. 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. 8.3. Postmenopausal for at least 1 year 8.4. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Exclusion criteria
Exclusion criteria: 1. History of thyroid disease or cardiovascular disease or diabetes 2. Any other clinically significant disorder 3. History of allergy to spices and herbal products 4. Intractable obesity or uncontrolled body weight, BMI greater than 40 kg/m^2 5. Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss 6. Recent, unexplained weight loss or gain 7. Positive Human Immunodeficiency Virus (HIV) test 8. History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis 9. History of motor weakness or peripheral sensory neuropathy 10. 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. Glucagon like peptide-1 3. Adiponectin 4. Ghrelin The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. | — |
Countries
India
Outcome results
None listed