Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09-006/Ob/Sp
Study information
Scientific title
Comparative efficacy and tolerability of a novel botanical extract LI 12508 and its formulation LI 12507F in the treatment and control of obesity: a randomised, double-blind placebo controlled clinical study
Acronym
Anti-obese nutraceuticals
Study hypothesis
Supplementation of herbal formulations might be useful for management of body weight in obese human subjects.
Ethics approval
Internal Review Board of ASR Academy of Medical Sciences (India) approved on the 10th February 2010 (Ref: ASRAMIRB 09006)
Study design
Randomised double blind placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
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 active groups. Each subject included in the third group is receiving matched placebo per day.
The study duration will be of 56 days. The visits and the evaluations are at the baseline, 14th day, 28th day and the 56th day.
Intervention type
Drug
Phase
Not Specified
Drug names
LI 12508, LI 12507F
Primary outcome measures
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. Adiponectin
3. Ghrelin
The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day.
Overall trial start date
07/03/2010
Overall trial end date
07/06/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
07/03/2010
Recruitment end date
07/06/2010
Locations
Countries of recruitment
India
Trial participating centre
Department of General Medicine
Eluru
534002
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
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23767862
Publication citations
-
Results
Stern JS, Peerson J, Mishra AT, Mathukumalli VS, Konda PR, Efficacy and tolerability of an herbal formulation for weight management., J Med Food, 2013, 16, 6, 529-537, doi: 10.1089/jmf.2012.0178.