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Evaluation of GCB-70 in Overweight Subjects

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ClinicalTrials.gov Identifier: NCT02703025
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Chemical Resources

Brief Summary:
Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: GCB-70 Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open level
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CLINICAL EVALUATION OF GCB-70 IN OVERWEIGHT SUBJECTS:An Add-On Study
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GCB 70 administered group
Green coffee bean extract capsule 500mg, BD
Dietary Supplement: GCB-70
green coffee bean extract




Primary Outcome Measures :
  1. weight loss [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Agrees to written as well as audio-visual informed consent
  2. Patients of either sex.
  3. BMI >25 kg/m2
  4. Aged 18-65 years
  5. Euthyroid
  6. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703025


Locations
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India
Department of Physiology, King George's Medical University, Lucknow, UP, India
Lucknow, Uttar Pradesh, India, 226003
Sponsors and Collaborators
Chemical Resources
Investigators
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Principal Investigator: Dr Narsingh Verma, MD Dept of Physiology,King George's Medical University, Lucknow, UP, India

Additional Information:
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Responsible Party: Chemical Resources
ClinicalTrials.gov Identifier: NCT02703025     History of Changes
Other Study ID Numbers: PROTOCOL NO. CR-GCB- 70/ 07/14
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chemical Resources:
Obesity, green coffee bean extract, weight management

Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes