Efficacy of three nutraceutical products of herbal origin in weight management of obese human subjects: a randomised, double blind, placebo controlled clinical study

Completed

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN37381706
• Lead Sponsor: aila Nutraceuticals (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Physical/anthropometric parameters:<br>1.1. Body weight<br>1.2. Body mass Index<br>1.3. Waist hip ratio<br>2. Biochemical parameters (serum/plasma):<br>2.1. Fasting glucose<br>2.2. Fasting insulin<br>2.3. Triglyceride<br>2.4. Cholesterol<br>2.5. High Density Lipoprotein (HDL) cholesterol<br>2.6. Low Density Lipoprotein (LDL) cholesterol<br><br>The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day.

Secondary Outcome Measures

Name	Time	Method
Obesity biomarkers (serum/plasma):<br>1. Leptin<br>2. Glucagon like peptide-1<br>3. Adiponectin<br>4. Ghrelin<br><br>The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day.