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Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors

Primary Purpose

Breast Cancer Survivors

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
green coffee
control
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Survivors

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • National Nutrition and Food Technology Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

green coffe

control

Arm Description

green coffe 2 capsuls of green coffe

2 capsuls of placebo

Outcomes

Primary Outcome Measures

gherlin
assed by elisa
Adiponectin
assed by elisa
Leptin
assed by elisa

Secondary Outcome Measures

body mass index
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight)

Full Information

First Posted
December 26, 2017
Last Updated
January 3, 2018
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03394690
Brief Title
Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
Official Title
the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2018 (Anticipated)
Primary Completion Date
February 12, 2019 (Anticipated)
Study Completion Date
August 12, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

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

5. Study Description

Brief Summary
To study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile 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, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
green coffe
Arm Type
Active Comparator
Arm Description
green coffe 2 capsuls of green coffe
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
2 capsuls of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
green coffee
Intervention Description
2 capsuls
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
2 capsuls
Primary Outcome Measure Information:
Title
gherlin
Description
assed by elisa
Time Frame
12 weeks
Title
Adiponectin
Description
assed by elisa
Time Frame
12 weeks
Title
Leptin
Description
assed by elisa
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body mass index
Description
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehsan Hejazi, PhD
Phone
+98-21-22077424
Email
ehsanhejazi@gmail.com
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors

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