CClinicalTrials.gg
CompletedNCT01738399COMETHUpdated Apr 23, 2015

Coffee and Metabolic Health Outcomes

An interventional study of Coffee and Placebo in Insulin Resistance, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to participants aged 35 Years to 69 Years. Per ClinicalTrials.gov, last updated 2015-04-23.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
35 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Insulin Resistance

Browse trials for

Keywords

  • Insulin resistance
  • Coffee
  • Glucose metabolism
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 128 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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.
  • 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 ).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Coffee

    Subjects take 4 cups of coffee mix per day for 24 weeks

    Dietary Supplement: Coffee

  • Placebo comparator
    Placebo

    Subjects take 4 cups of placebo per day for 24 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCoffee
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Change in insulin sensitivity when compared to baseline as measured using the euglycemic hyperinsulinemic clamp.

    Time frame: Baseline and 24 weeks

Secondary outcomes

  1. Change in fasting plasma glucose concentration from baseline to 12 weeks

    Time frame: Baseline, 12 weeks

  2. Change in fasting plasma glucose concentration from baseline to 24 weeks

    Time frame: Baseline, 24 weeks

  3. Change in fasting plasma total adiponectin concentrations from baseline to 12 weeks

    Time frame: Baseline, 12 weeks

  4. Change in fasting plasma total adiponectin concentrations from baseline to 24 weeks

    Time frame: Baseline, 24 weeks

07

Study locations

1 site
  • Saw Swee Hock School of Public Health
    Singapore, 117597, Singapore
08

References and documents

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 31891374 ↗
  • Alperet 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01738399
Lead sponsor
National University Hospital, Singapore
Collaborators
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Nov 30, 2012
Start date
Apr 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 23, 2015

Study contacts

Rob M van Dam
principal investigator · Saw Swee Hock School of Public Health, National University of Singapore

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion