Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Primary Purpose
Breast Cancer Survivors
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
green coffee
control
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Survivors
Eligibility Criteria
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
Sites / Locations
- National Nutrition and Food Technology Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
green coffe
control
Arm Description
2 capsuls of green coffe
2 capsuls
Outcomes
Primary Outcome Measures
Tumor necrosis factor alpha
assessed by ELISA
Interleukin 6
assessed by ELISA
Secondary Outcome Measures
body mass index
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Full Information
NCT ID
NCT03395561
First Posted
December 26, 2017
Last Updated
January 3, 2018
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT03395561
Brief Title
Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Official Title
the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2018 (Anticipated)
Primary Completion Date
January 11, 2019 (Anticipated)
Study Completion Date
October 11, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic inflammation and oxidative stress 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, adropin, irisin, vaspine, systemic inflammation and oxidative stress will be assessed and compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
green coffe
Arm Type
Active Comparator
Arm Description
2 capsuls of green coffe
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
2 capsuls
Intervention Type
Dietary Supplement
Intervention Name(s)
green coffee
Intervention Description
2 capsuls
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
2 capsuls
Primary Outcome Measure Information:
Title
Tumor necrosis factor alpha
Description
assessed by ELISA
Time Frame
12 weeks
Title
Interleukin 6
Description
assessed by ELISA
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body mass index
Description
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehsan Hejazi, PhD
Phone
+98-21-22077424
Email
ehsanhejazi@gmail.com
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
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