Breast Cancer SurvivorsNCT03394690
Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
A study testing green coffee in people with Breast Cancer Survivors, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- green coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 12 Mar 2018to 12 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 to 70 years
- Body Mass Index (BMI) between 25-40 treatment is over
Who cannot join
- -Taking any kind of supplement for weight reduction
- pregnancy or lactation
- Professional athletes
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
National Nutrition and Food Technology Research Institute
Tehran
About this study
Official title: the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
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.
- Conditions
- Breast Cancer Survivors
- Being tested
- green coffee, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green coffeeDietary supplement
2 capsuls
controlOther
2 capsuls
| Study group | Role | What they receive |
|---|---|---|
| green coffe | Active comparator | green coffe 2 capsuls of green coffe Receives: Dietary Supplement: green coffee |
| control | Placebo comparator | 2 capsuls of placebo Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
gherlin
assed by elisa
Measured: 12 weeks
Adiponectin
assed by elisa
Measured: 12 weeks
Leptin
assed by elisa
Measured: 12 weeks
Secondary outcomes (1)
body mass index
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start12 Mar 2018 (estimated)
- Primary completion12 Feb 2019 (estimated)
- Study completion12 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394690
- Sponsor's protocol ID
- 911
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03394690
- Acronym / sponsor ID
- 911
- Conditions
- Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 12 Mar 2018 (estimated)
- Primary completion
- 12 Feb 2019 (estimated)
- Study completion
- 12 Aug 2019 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green coffe | Active comparator | Dietary Supplement: green coffeegreen coffe 2 capsuls of green coffe |
| control | Placebo comparator | Other: control2 capsuls of placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 to 70 years
- Body Mass Index (BMI) between 25-40 treatment is over
Key exclusion criteria (3 listed)
- -Taking any kind of supplement for weight reduction
- pregnancy or lactation
- Professional athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green coffee2 capsuls | Dietary supplement | green coffe |
| control2 capsuls | Other | control |
Primary outcome
gherlin
Time frame: 12 weeks
assed by elisa
Adiponectin
Time frame: 12 weeks
assed by elisa
Leptin
Time frame: 12 weeks
assed by elisa
1 secondary outcome
body mass index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green coffee in people with Breast Cancer Survivors, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehsan Hejazi, PhD (+98-21-22077424, ehsanhejazi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gherlin (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.