Insulin ResistanceCOMETHNCT01738399
Coffee and Metabolic Health Outcomes
A study testing Coffee in people with Insulin Resistance, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
The purpose of the study is to investigate the long-term (24 weeks) effects of coffee consumption on insulin sensitivity in insulin resistant individuals. Read more about this study
- Who is it for?
- Ages 35 to 69 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesSingapore
- Study dates
- Apr 2012to Dec 2014
- 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 35 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects classified as being insulin-resistant in the screening visit. Subjects should have a non-diabetic fasting plasma glucose concentration (< 7.0 mM) and a HOMA-IR > 2.2. The HOMA-IR was demonstrated as a reliable indicator of insulin resistance strongly correlated with values obtained by clamp (4). The cut-off value of the HOMA-IR was defined according to data obtained in the Singapore cohort. It corresponds to the 75th percentile of the population. The HOMA-IR cut-off was subsequently revised to ≥ 1.3 to increase recruitment rates.
- Age: ≥ 35 to ≤ 69 years old
- Body mass index : ≥ 22.5 to ≤ 35.4 kg/m2
- Users of at least 1 cups of caffeinated coffee per day who are willing to be randomized to any of the interventions.
- Subjects should be willing to stop consuming caffeinated soft drinks or supplements during the study and to drink coffee with non-dairy creamer.
- Non-smokers (< 1 cigarette per week)
- Participants have been weight stable for at least -8 weeks pre-ceding the screening visit (± 2.5 kgs).
- Chinese, Malay and Indian ethnicity
Who cannot join
- Subjects representing one or more of the following criteria are excluded from participation in the study:
- Any condition/illness that may affect the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer, clotting or bleeding disorders,allergy to the test beverage, allergy to insulin, according to a detailed medical history.
- Participants who are allergic to foods may be excluded based on the investigator's discretion.
- Participants consume > 2 alcoholic servings/day on a regular basis and > 8 caffeinated servings (based on tea and coffee)/day
- Present drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, anti-hypertensives. These conditions will be screened based on subject reporting. Participants will be asked to bring in their current medications at the time of screening, and these will be checked by the study-staff.
- Subject is taking traditional medications, herbal or dietary supplements that may affect the study outcome in the opinion of the investigators.
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- Subject who cannot be expected to comply with the study procedures in the opinion of the investigators.
- Currently participating or having participated in another clinical trial during the last 12 weeks prior to the beginning of this study.
- Premenopausal women with self-reported irregular menstrual cycles or peri-menopausal women (participants who stopped getting their menses for less than 48 weeks ).
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Saw Swee Hock School of Public Health
Singapore, Singapore, 117597
Saw Swee Hock School of Public Health
Singapore, 117597
About this study
Official title: Influence of Coffee Consumption on Insulin Sensitivity in Overweight and Insulin Resistant Subjects.
The purpose of the study is to investigate the long-term (24 weeks) effects of coffee consumption on insulin sensitivity in insulin resistant individuals.
Read the detailed description
Coffee is a major source of the phenolic acid chlorogenic acid and a substantial source of trigonelline, niacin, lignans magnesium, and potassium. Several of these compounds have been shown to improve glucose metabolism in animal models. Consumption of coffee was inversely associated with the risk of type-2 diabetes in prospective cohort studies across the world. Consumption of 3 to 4 cups of coffee per day was associated with an approximately 25% lower risk of type-2 diabetes. However, direct evidence of the efficacy of coffee to reduce blood glucose and insulin resistance parameters in humans from randomized trials is still lacking. In recent small trials of short duration (up to 6 weeks) coffee consumption increased levels of the insulin-sensitizing hormone adiponectin, but did not significantly improve insulin sensitivity These results suggest that a larger longer-term trial of the effects of coffee consumption on directly measured insulin sensitivity is warranted.
- Conditions
- Insulin Resistance
- Being tested
- Coffee, Placebo
- Keywords
- Insulin resistance, Coffee, Glucose metabolism
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Experimental | Subjects take 4 cups of coffee mix per day for 24 weeks Receives: Dietary Supplement: Coffee |
| Placebo | Placebo comparator | Subjects take 4 cups of placebo per day for 24 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity when compared to baseline as measured using the euglycemic hyperinsulinemic clamp.
Measured: Baseline and 24 weeks
Secondary outcomes (4)
Change in fasting plasma glucose concentration from baseline to 12 weeks
Measured: Baseline, 12 weeks
Change in fasting plasma glucose concentration from baseline to 24 weeks
Measured: Baseline, 24 weeks
Change in fasting plasma total adiponectin concentrations from baseline to 12 weeks
Measured: Baseline, 12 weeks
Change in fasting plasma total adiponectin concentrations from baseline to 24 weeks
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Rob M van Dam, Principal investigator, Saw Swee Hock School of Public Health, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738399
- Sponsor's protocol ID
- 11.09.NRC
- Acronym
- COMETH
- Status last verified
- Mar 2012
- First submitted
- 28 Nov 2012
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alperet DJ, Rebello SA, Khoo EY, Tay Z, Seah SS, Tai BC, Tai ES, Emady-Azar S, Chou CJ, Darimont C, van Dam RM. The effect of coffee consumption on insulin sensitivity and other biological risk factors for type 2 diabetes: a randomized placebo-controlled trial. Am J Clin Nutr. 2020 Feb 1;111(2):448-458. doi: 10.1093/ajcn/nqz306.
PubMed 31891374Alperet DJ, Rebello SA, Khoo EY, Tay Z, Seah SS, Tai BC, Emady-Azar S, Chou CJ, Darimont C, van Dam RM. A randomized placebo-controlled trial of the effect of coffee consumption on insulin sensitivity: Design and baseline characteristics of the Coffee for METabolic Health (COMETH) study. Contemp Clin Trials Commun. 2016 Aug 2;4:105-117. doi: 10.1016/j.conctc.2016.06.013. eCollection 2016 Dec 15.
PubMed 29736473
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Coffee Consumption on Insulin Sensitivity in Overweight and Insulin Resistant Subjects.
- ClinicalTrials.gov ID
- NCT01738399
- Acronym / sponsor ID
- COMETH / 11.09.NRC
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, Coffee, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2012 (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 the study is to investigate the long-term (24 weeks) effects of coffee consumption on insulin sensitivity in insulin resistant individuals.
Detailed description
Coffee is a major source of the phenolic acid chlorogenic acid and a substantial source of trigonelline, niacin, lignans magnesium, and potassium. Several of these compounds have been shown to improve glucose metabolism in animal models. Consumption of coffee was inversely associated with the risk of type-2 diabetes in prospective cohort studies across the world. Consumption of 3 to 4 cups of coffee per day was associated with an approximately 25% lower risk of type-2 diabetes. However, direct evidence of the efficacy of coffee to reduce blood glucose and insulin resistance parameters in humans from randomized trials is still lacking. In recent small trials of short duration (up to 6 weeks) coffee consumption increased levels of the insulin-sensitizing hormone adiponectin, but did not significantly improve insulin sensitivity These results suggest that a larger longer-term trial of the effects of coffee consumption on directly measured insulin sensitivity is warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee | Experimental | Dietary Supplement: CoffeeSubjects take 4 cups of coffee mix per day for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects take 4 cups of placebo per day for 24 weeks |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects classified as being insulin-resistant in the screening visit. Subjects should have a non-diabetic fasting plasma glucose concentration (< 7.0 mM) and a HOMA-IR > 2.2. The HOMA-IR was demonstrated as a reliable indicator of insulin resistance strongly correlated with values obtained by clamp (4). The cut-off value of the HOMA-IR was defined according to data obtained in the Singapore cohort. It corresponds to the 75th percentile of the population. The HOMA-IR cut-off was subsequently revised to ≥ 1.3 to increase recruitment rates.
- Age: ≥ 35 to ≤ 69 years old
- Body mass index : ≥ 22.5 to ≤ 35.4 kg/m2
- Users of at least 1 cups of caffeinated coffee per day who are willing to be randomized to any of the interventions.
- Subjects should be willing to stop consuming caffeinated soft drinks or supplements during the study and to drink coffee with non-dairy creamer.
Key exclusion criteria (9 listed)
- Subjects representing one or more of the following criteria are excluded from participation in the study:
- Any condition/illness that may affect the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer, clotting or bleeding disorders,allergy to the test beverage, allergy to insulin, according to a detailed medical history.
- Participants who are allergic to foods may be excluded based on the investigator's discretion.
- Participants consume > 2 alcoholic servings/day on a regular basis and > 8 caffeinated servings (based on tea and coffee)/day
- Present drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, anti-hypertensives. These conditions will be screened based on subject reporting. Participants will be asked to bring in their current medications at the time of screening, and these will be checked by the study-staff.
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 |
|---|---|---|
| Coffee | Dietary supplement | Coffee |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in insulin sensitivity when compared to baseline as measured using the euglycemic hyperinsulinemic clamp.
Time frame: Baseline and 24 weeks
4 secondary outcomes
Change in fasting plasma glucose concentration from baseline to 12 weeks
Time frame: Baseline, 12 weeks
Change in fasting plasma glucose concentration from baseline to 24 weeks
Time frame: Baseline, 24 weeks
Change in fasting plasma total adiponectin concentrations from baseline to 12 weeks
Time frame: Baseline, 12 weeks
Change in fasting plasma total adiponectin concentrations from baseline to 24 weeks
Time frame: Baseline, 24 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 23 Apr 2015.
- Derived from this study: PubMed 31891374Alperet DJ, Rebello SA, Khoo EY, Tay Z, Seah SS, Tai BC, Tai ES, Emady-Azar S, Chou CJ, Darimont C, van Dam RM. The effect of coffee consumption on insulin sensitivity and other biological risk factors for type 2 diabetes: a randomized placebo-controlled trial. Am J Clin Nutr. 2020 Feb 1;111(2):448-458. doi: 10.1093/ajcn/nqz306.
- Derived from this study: PubMed 29736473Alperet DJ, Rebello SA, Khoo EY, Tay Z, Seah SS, Tai BC, Emady-Azar S, Chou CJ, Darimont C, van Dam RM. A randomized placebo-controlled trial of the effect of coffee consumption on insulin sensitivity: Design and baseline characteristics of the Coffee for METabolic Health (COMETH) study. Contemp Clin Trials Commun. 2016 Aug 2;4:105-117. doi: 10.1016/j.conctc.2016.06.013. eCollection 2016 Dec 15.
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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.
Rob M van Dam principal investigator
Saw Swee Hock School of Public Health, National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee in people with Insulin Resistance, run by National University Hospital, Singapore at 2 sites in Singapore.
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 8 inclusion and 9 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
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?
Change in insulin sensitivity when compared to baseline as measured using the euglycemic hyperinsulinemic clamp. (time frame: Baseline and 24 weeks). 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 NCT01738399, which also lists 2 linked publications.
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 23 Apr 2015.