Comparative efficacy and tolerability of a novel botanical extract LI 12508 and its formulation LI 12507F in the treatment and control of obesity

Completed

Conditions: Obesity
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN45078827

Lead Sponsor: aila Nutraceuticals (India)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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