Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/001/PHF Ob
Study information
Scientific title
Acronym
Anti-obese Nutraceuticals
Study hypothesis
Public Title: Clinical efficacy of three nutraceutical products of herbal origin in obese subjects
Supplementation of three natural polyherbal formulations will be helpful for management of weight control in obese human subjects.
Ethics approval
Ethics approval received from the Internal Review Board of ASR Academy of Medical Sciences (India) on the 5th October 2007 (ref: 07-01/IB/PHF Ob).
Study design
This is a randomised, double blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Obesity
Intervention
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 daily for the active treatment groups. Each subject in the fourth group will receive color matched equal amount of placebo per day.
The study duration will be 56 days. The visits and the evaluations will be at the baseline, 14th day, 28th day, and the 56th day.
Intervention type
Drug
Phase
Not Specified
Drug names
Adipolean, Adipolite, Betelean
Primary outcome measure
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 outcome measures
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.
Overall trial start date
15/11/2007
Overall trial end date
20/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
15/11/2007
Recruitment end date
20/01/2008
Locations
Countries of recruitment
India
Trial participating centre
Department of General Medicine
Eluru
534 002
India
Funders
Funder type
Industry
Funder name
Laila Nutraceuticals (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22995673
Publication citations
-
Results
Sengupta K, Mishra AT, Rao MK, Sarma KV, Krishnaraju AV, Trimurtulu G, Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized double blind placebo controlled clinical study., Lipids Health Dis, 2012, 11, 122, doi: 10.1186/1476-511X-11-122.