Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/11/2007
Date assigned
22/11/2007
Last edited
28/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Artatrana Mishra

ORCID ID

Contact details

Department of General Medicine
ASR Academy of Medical Sciences
Eluru
534 002
India

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 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. 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

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

Sponsor information

Organisation

Laila Nutraceuticals (India)

Sponsor details

Unit-6 & 7
Phase-III
Jawahar Autonagar
Vijayawada
520007
India

Sponsor type

Industry

Website

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22995673

Publication citations

  1. 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.

Additional files

Editorial Notes