Weight LossNCT02703025
Evaluation of GCB-70 in Overweight Subjects
A study testing GCB-70 in people with Weight Loss, run by Chemical Resources at 1 site in India.
Trial summary
Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- GCB-70
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Physiology, King George's Medical University, Lucknow, UP, India
Lucknow, Uttar Pradesh, 226003
About this study
Official title: CLINICAL EVALUATION OF GCB-70 IN OVERWEIGHT SUBJECTS:An Add-On Study
Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study
Read the 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
- Conditions
- Weight Loss
- Being tested
- GCB-70
- Keywords
- Obesity, green coffee bean extract, weight management
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCB-70Dietary supplement
green coffee bean extract
| Study group | Role | What they receive |
|---|---|---|
| GCB 70 administered group | Experimental | Green coffee bean extract capsule 500mg, BD Receives: Dietary Supplement: GCB-70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open level
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemical Resources
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Narsingh Verma, MD, Principal investigator, Dept of Physiology,King George's Medical University, Lucknow, UP, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703025
- Sponsor's protocol ID
- PROTOCOL NO. CR-GCB- 70/ 07/14
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EVALUATION OF GCB-70 IN OVERWEIGHT SUBJECTS:An Add-On Study
- ClinicalTrials.gov ID
- NCT02703025
- Acronym / sponsor ID
- PROTOCOL NO. CR-GCB- 70/ 07/14
- Conditions
- Weight Loss
- Keywords
- Obesity, green coffee bean extract, weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Chemical ResourcesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open level
| Arm | Type | Receives |
|---|---|---|
| GCB 70 administered group | Experimental | Dietary Supplement: GCB-70Green coffee bean extract capsule 500mg, BD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agrees to written as well as audio-visual informed consent
- Patients of either sex.
- BMI >25 kg/m2
- Aged 18-65 years
- Euthyroid
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCB-70green coffee bean extract | Dietary supplement | GCB 70 administered group |
Primary outcome
weight loss
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Narsingh Verma, MD principal investigator
Dept of Physiology,King George's Medical University, Lucknow, UP, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GCB-70 in people with Weight Loss, run by Chemical Resources at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.