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Trial record 3 of 5 for:    green coffee extract

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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivors Dietary Supplement: green coffee Other: control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Estimated Study Start Date : February 11, 2018
Estimated Primary Completion Date : January 11, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: green coffe
2 capsuls of green coffe
Dietary Supplement: green coffee
2 capsuls

Placebo Comparator: control
2 capsuls
Other: control
2 capsuls




Primary Outcome Measures :
  1. Tumor necrosis factor alpha [ Time Frame: 12 weeks ]
    assessed by ELISA

  2. Interleukin 6 [ Time Frame: 12 weeks ]
    assessed by ELISA


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03395561


Contacts
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Contact: Ehsan Hejazi, PhD +98-21-22077424 ehsanhejazi@gmail.com

Locations
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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
National Nutrition and Food Technology Institute

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Responsible Party: Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03395561     History of Changes
Other Study ID Numbers: 811
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Inflammation
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes