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

Breast Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03395561
• Other study ID #: 811
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2017
• Last updated: January 3, 2018
• Start date: February 11, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: December 2017
• Source: National Nutrition and Food Technology Institute
• Contact: Ehsan Hejazi, PhD
• Phone: +98-21-22077424
• Email: ehsanhejazi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 11, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Inflammation

Intervention

Dietary Supplement:
• green coffee
2 capsuls

Other:
• control
2 capsuls

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor necrosis factor alpha	assessed by ELISA	12 weeks
Primary	Interleukin 6	assessed by ELISA	12 weeks
Secondary	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.	12 weeks