- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394690
Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
January 3, 2018 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
To study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile in breast cancer survivors.50
breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too.
At the first and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ehsan Hejazi, PhD
- Phone Number: +98-21-22077424
- Email: ehsanhejazi@gmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- National Nutrition and Food Technology Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age of 18 to 70 years
- Body Mass Index (BMI) between 25-40 treatment is over
Exclusion Criteria:
- -Taking any kind of supplement for weight reduction
- pregnancy or lactation
- Professional athletes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control
2 capsuls of placebo
|
2 capsuls
|
Active Comparator: green coffe
green coffe 2 capsuls of green coffe
|
2 capsuls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gherlin
Time Frame: 12 weeks
|
assed by elisa
|
12 weeks
|
Adiponectin
Time Frame: 12 weeks
|
assed by elisa
|
12 weeks
|
Leptin
Time Frame: 12 weeks
|
assed by elisa
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body mass index
Time Frame: 12 weeks
|
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 12, 2018
Primary Completion (Anticipated)
February 12, 2019
Study Completion (Anticipated)
August 12, 2019
Study Registration Dates
First Submitted
December 26, 2017
First Submitted That Met QC Criteria
January 3, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 3, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 911 (Urochester)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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