Evaluation of GCB-70 in Overweight Subjects
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
GCB-70
Sponsored by
About this trial
This is an interventional supportive care trial for Weight Loss focused on measuring Obesity, green coffee bean extract, weight management
Eligibility Criteria
Inclusion Criteria:
- Agrees to written as well as audio-visual informed consent
- Patients of either sex.
- BMI >25 kg/m2
- Aged 18-65 years
- Euthyroid
- Not receiving any steroids
Exclusion Criteria:
i. Uncooperative Subjects ii. Lactating and Pregnant or planning to conceive females. iii. Physically/ mentally unwell as certified by physician-in-charge. iv. Participation in any other clinical trial with in the last 30 days
Sites / Locations
- Department of Physiology, King George's Medical University, Lucknow, UP, India
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GCB 70 administered group
Arm Description
Green coffee bean extract capsule 500mg, BD
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
Full Information
NCT ID
NCT02703025
First Posted
September 30, 2015
Last Updated
February 19, 2017
Sponsor
Chemical Resources
1. Study Identification
Unique Protocol Identification Number
NCT02703025
Brief Title
Evaluation of GCB-70 in Overweight Subjects
Official Title
CLINICAL EVALUATION OF GCB-70 IN OVERWEIGHT SUBJECTS:An Add-On Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemical Resources
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study
Detailed Description
In recent years the prevalence of obesity has increased reaching epidemic levels. Obesity can be defined as excess accumulation of body fat arising from a sustained or a periodic positive energy balance that is when energy intake exceeds energy expenditure. Overweight and obesity is based on Body Mass Index (BMI) Accordingly to the World Health Organization (WHO) classifies individuals with BMI 25-29.99 kg/m2 as overweight while individuals with BMI≥ 30 kg/m2 are termed obese. Apart from being a major contributor to chronic disease burden and mortality, obesity-particularly abdominal obesity, is also closely related to the metabolic syndrome, a cluster of diseases that encompasses the following conditions Dyslipidemia, Hypertension Glucose intolerance and insulin resistance.Abdominal obesity The World Health Organization predicts there will be 2.3 billion overweight adults in the world by 2015, and more than 700 million of them will be obese. Worldwide obesity has more than doubled since 1980. In 2008, 1.5 billion adults, 20 years of age and older, were overweight. Of these, over 200 million men and nearly 300 million women were obese. Over 65% of the world population lives in countries where overweight and obesity kills more people than underweight .
Overweight and obesity have become a serious health concern . Different weight management strategies are presently utilized and a variety of weight loss supplements sold as "slimming aids" are readily available. However, the efficacy of some of these food supplements remains uncertain. With the high cost of prescription weight loss drugs and the fear of side effects, the general public is turning to nutraceuticals. One such supplement is the green coffee extract (GCE).GCE is present in green or raw coffee.
Coffee (Coffea L.) is the world's favourite beverage and the second-most traded commodity after oil. In 2009/10 coffee accounted for exports worth an estimated US$ 15.4 billion, when some 93.4 million bags were shipped, with total coffee sector employment estimated at about 26 million people in 52 producing countries. Arabica coffee (Coffea arabica L.) and robusta coffee (C. canephora Pierre ex A.Froehner) are the two main species used in the production of coffee. 66% of the world production mostly comes from Coffea arabica L. and 34% from Coffea canephora. Coffee belongs to family Rubiaceae in the genus Coffea.
GCB-70 is obtained from raw seeds or beans of Coffee. In producing the normal coffee for sale, the berries are roasted to produce the traditional beverage. However, no roasting is done for green extract so as to preserve important components
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Obesity, green coffee bean extract, weight management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open level
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GCB 70 administered group
Arm Type
Experimental
Arm Description
Green coffee bean extract capsule 500mg, BD
Intervention Type
Dietary Supplement
Intervention Name(s)
GCB-70
Intervention Description
green coffee bean extract
Primary Outcome Measure Information:
Title
weight loss
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Agrees to written as well as audio-visual informed consent
Patients of either sex.
BMI >25 kg/m2
Aged 18-65 years
Euthyroid
Not receiving any steroids
Exclusion Criteria:
i. Uncooperative Subjects ii. Lactating and Pregnant or planning to conceive females. iii. Physically/ mentally unwell as certified by physician-in-charge. iv. Participation in any other clinical trial with in the last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Narsingh Verma, MD
Organizational Affiliation
Dept of Physiology,King George's Medical University, Lucknow, UP, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiology, King George's Medical University, Lucknow, UP, India
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.hindawi.com/journals/grp/2011/382852/ref/
Description
The Use of Green Coffee Extract as a Weight Loss Supplement: A Systematic Review and Meta-Analysis of Randomised Clinical Trials
Learn more about this trial
Evaluation of GCB-70 in Overweight Subjects
We'll reach out to this number within 24 hrs