Metabolic SyndromeNCT03265184
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
A study testing green coffee extract in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute.
Trial summary
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- green coffee extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 18 Jul 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
Who cannot join
- insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
About this study
Official title: Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets
- Conditions
- Metabolic Syndrome
- Being tested
- green coffee extract
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green coffee extractDietary supplement
Patients in treatment group take 400 mg GCE supplements twice a day for tow month
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC Receives: Dietary Supplement: green coffee extract |
| placebo group | Placebo comparator | placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch Receives: Dietary Supplement: green coffee extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
intercellular adhesion molecule-1 (ICAM-1)
Measured: 8 weeks
interleukin-6 (IL-6)
Measured: 8 weeks
high sensitivity C-reactive protein (hs-CRP)
Measured: 8 weeks
malondialdehyde (MDA)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jan 2017
- Primary completion12 Jun 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
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
- NCT03265184
- Sponsor's protocol ID
- NationalNFTI1355
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03265184
- Acronym / sponsor ID
- NationalNFTI1355
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 29 Aug 2017 (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.
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: green coffee extract400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC |
| placebo group | Placebo comparator | Dietary Supplement: green coffee extractplacebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
Key exclusion criteria (1 listed)
- insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
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 coffee extractPatients in treatment group take 400 mg GCE supplements twice a day for tow month | Dietary supplement | intervention group, placebo group |
Primary outcome
intercellular adhesion molecule-1 (ICAM-1)
Time frame: 8 weeks
interleukin-6 (IL-6)
Time frame: 8 weeks
high sensitivity C-reactive protein (hs-CRP)
Time frame: 8 weeks
malondialdehyde (MDA)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing green coffee extract in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intercellular adhesion molecule-1 (ICAM-1) (time frame: 8 weeks). The study lists 4 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 29 Aug 2017.