NCT03395561

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 11, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2019

Completed
Last Updated

January 10, 2018

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

December 26, 2017

Last Update Submit

January 3, 2018

Conditions

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (2)

  • Tumor necrosis factor alpha

    assessed by ELISA

    12 weeks

  • Interleukin 6

    assessed by ELISA

    12 weeks

Secondary Outcomes (1)

  • body mass index

    12 weeks

Study Arms (2)

green coffe

ACTIVE COMPARATOR

2 capsuls of green coffe

Dietary Supplement: green coffee

control

PLACEBO COMPARATOR

2 capsuls

Other: control

Interventions

green coffeeDIETARY_SUPPLEMENT

2 capsuls

green coffe
controlOTHER

2 capsuls

control

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 to 70 years
  • Body Mass Index (BMI) between 25-40 treatment is over

You may not qualify if:

  • Taking any kind of supplement for weight reduction
  • pregnancy or lactation
  • Professional athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

RECRUITING

Central Study Contacts

Ehsan Hejazi, PhD

CONTACT

+98-21-22077424ehsanhejazi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 10, 2018

Study Start

February 11, 2018

Primary Completion

January 11, 2019

Study Completion

October 11, 2019

Last Updated

January 10, 2018

Record last verified: 2017-12

Locations

IR(1)