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

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03394690
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 2.9

Study Details

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.

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 Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
• Anticipated Study Start Date: Mar 12, 2018
• Anticipated Primary Completion Date: Feb 12, 2019
• Anticipated Study Completion Date: Aug 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: green coffe green coffe 2 capsuls of green coffe	Dietary Supplement: green coffee; 2 capsuls
Placebo Comparator: control 2 capsuls of placebo	Other: control; 2 capsuls

Outcome Measures

Primary Outcome Measures

1. gherlin [12 weeks]

   assed by elisa

2. Adiponectin [12 weeks]

   assed by elisa

3. Leptin [12 weeks]

   assed by elisa

Secondary Outcome Measures

1. body mass index [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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: NCT03394690
• Other Study ID Numbers: 911
• First Posted: Jan 9, 2018
• Last Update Posted: Jan 9, 2018
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jan 9, 2018