Type 2 Diabetes Nonalcoholic Fatty LiverPhase 2/3NCT02929901
The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes
A Phase 2/3 study testing caffeine and chlorogenic acid, caffeine and chlorogenic acid in people with Type 2 Diabetes Nonalcoholic Fatty Liver, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Nonalcoholic Fatty Liver
- What is being tested?
- caffeine and chlorogenic acid, caffeine and chlorogenic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Dec 2016to Mar 2019
- Phase
- Phase 2/3
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
- CAPscore >263
Who cannot join
- Criteria:
- Taking any kind of antibiotics two weeks before recruitment;
- History of alcohol consumption ;
- pregnancy or lactation;
- Professional athletes;
- Other liver disease (viral/etc);
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- High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
- A history of Cardiovascular disease;
- Renal disease, Celiac disease, Cirrhosis;
- History of Upper Gastrointestinal surgery ;
- A history of hypothyroidism or Cushing's syndrome;
- History of drug dependence;
- Body mass index (BMI) ≥35 kg/m2;
- A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
- Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
- Use of weight loss medications
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
- Conditions
- Type 2 Diabetes Nonalcoholic Fatty Liver
- Being tested
- caffeine and chlorogenic acid, caffeine, chlorogenic acid, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine and chlorogenic acidDietary supplement
caffeine plus chlorogenic acid
caffeineDietary supplement
caffeine plus placebo
chlorogenic acidDietary supplement
chlorogenic acid plus placebo
placeboDietary supplement
placebo plus placebo
| Study group | Role | What they receive |
|---|---|---|
| caffeine and chlorogeinc acid | Active comparator | caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months Receives: Dietary Supplement: caffeine and chlorogenic acid |
| caffeine | Active comparator | caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months Receives: Dietary Supplement: caffeine |
| chlorogenic acid | Active comparator | chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months Receives: Dietary Supplement: chlorogenic acid |
| placebo | Placebo comparator | placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic steatosis
measured by CAP score using Fibroscan
Measured: 6 months
Secondary outcomes (6)
Glucose
Measured: 6 months
Glycated hemoglobin (HBA1C)
Measured: 6 months
alanine aminotransferase (ALT)
Measured: 6 months
aspartate aminotransferase (ALS)
Measured: 6 months
High sensitive C reactive protein ( hs- CRP)
Measured: 6 months
gut microbiota
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Nonalcoholic Fatty LiverStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT02929901
- Sponsor's protocol ID
- 147
- Status last verified
- Apr 2019
- First submitted
- 9 Oct 2016
- Last updated
- 1 May 2019
- Results posted
- No
Publications
Mansour A, Mohajeri-Tehrani MR, Karimi S, Sanginabadi M, Poustchi H, Enayati S, Asgarbeik S, Nasrollahzadeh J, Hekmatdoost A. Short term effects of coffee components consumption on gut microbiota in patients with non-alcoholic fatty liver and diabetes: A pilot randomized placebo-controlled, clinical trial. EXCLI J. 2020 Mar 2;19:241-250. doi: 10.17179/excli2019-2021. eCollection 2020.
PubMed 32256270
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02929901
- Acronym / sponsor ID
- 147
- Conditions
- Type 2 Diabetes Nonalcoholic Fatty Liver
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Oct 2016 (estimated)
- 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.
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| caffeine and chlorogeinc acid | Active comparator | Dietary Supplement: caffeine and chlorogenic acidcaffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months |
| caffeine | Active comparator | Dietary Supplement: caffeinecaffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months |
| chlorogenic acid | Active comparator | Dietary Supplement: chlorogenic acidchlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
- CAPscore >263
Key exclusion criteria (16 listed)
- Criteria:
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 |
|---|---|---|
| caffeine and chlorogenic acidcaffeine plus chlorogenic acid | Dietary supplement | caffeine and chlorogeinc acid |
| caffeinecaffeine plus placebo | Dietary supplement | caffeine |
| chlorogenic acidchlorogenic acid plus placebo | Dietary supplement | chlorogenic acid |
| placeboplacebo plus placebo | Dietary supplement | placebo |
Primary outcome
Hepatic steatosis
Time frame: 6 months
measured by CAP score using Fibroscan
6 secondary outcomes
Glucose
Time frame: 6 months
Glycated hemoglobin (HBA1C)
Time frame: 6 months
alanine aminotransferase (ALT)
Time frame: 6 months
aspartate aminotransferase (ALS)
Time frame: 6 months
High sensitive C reactive protein ( hs- CRP)
Time frame: 6 months
gut microbiota
Time frame: 3 months
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 1 May 2019.
- Derived from this study: PubMed 32256270Mansour A, Mohajeri-Tehrani MR, Karimi S, Sanginabadi M, Poustchi H, Enayati S, Asgarbeik S, Nasrollahzadeh J, Hekmatdoost A. Short term effects of coffee components consumption on gut microbiota in patients with non-alcoholic fatty liver and diabetes: A pilot randomized placebo-controlled, clinical trial. EXCLI J. 2020 Mar 2;19:241-250. doi: 10.17179/excli2019-2021. eCollection 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing caffeine and chlorogenic acid, caffeine and chlorogenic acid in people with Type 2 Diabetes Nonalcoholic Fatty Liver, 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 16 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 1 May 2019. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hepatic steatosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929901, which also lists 1 linked publication.
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 1 May 2019.