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Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03395561
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Tracking Information
First Submitted Date  ICMJE December 26, 2017
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date January 10, 2018
Estimated Study Start Date  ICMJE February 11, 2018
Estimated Primary Completion Date January 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Tumor necrosis factor alpha [ Time Frame: 12 weeks ]
    assessed by ELISA
  • Interleukin 6 [ Time Frame: 12 weeks ]
    assessed by ELISA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
body mass index [ Time Frame: 12 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Official Title  ICMJE the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Survivors
Intervention  ICMJE
  • Dietary Supplement: green coffee
    2 capsuls
  • Other: control
    2 capsuls
Study Arms  ICMJE
  • Active Comparator: green coffe
    2 capsuls of green coffe
    Intervention: Dietary Supplement: green coffee
  • Placebo Comparator: control
    2 capsuls
    Intervention: Other: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 11, 2019
Estimated Primary Completion Date January 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ehsan Hejazi, PhD +98-21-22077424 ehsanhejazi@gmail.com
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395561
Other Study ID Numbers  ICMJE 811
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Study Sponsor  ICMJE National Nutrition and Food Technology Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Nutrition and Food Technology Institute
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP