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

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03395561

Collaborator

(none)

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivors	Dietary Supplement: green coffee Other: control	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Feb 11, 2018

Anticipated Primary Completion Date :

Jan 11, 2019

Anticipated Study Completion Date :

Oct 11, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tumor necrosis factor alpha [12 weeks]
assessed by ELISA
Interleukin 6 [12 weeks]
assessed by ELISA

Secondary Outcome Measures

body mass index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Nutrition and Food Technology Research Institute	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT03395561

Other Study ID Numbers:

First Posted:

Jan 10, 2018

Last Update Posted:

Jan 10, 2018

Last Verified:

Dec 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Inflammation

Study Results

No Results Posted as of Jan 10, 2018