NCT01738399

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 23, 2015

Status Verified

March 1, 2012

Enrollment Period

2.7 years

First QC Date

November 28, 2012

Last Update Submit

April 21, 2015

Conditions

Insulin Resistance

Keywords

Insulin resistanceCoffeeGlucose metabolism

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 24 weeks

Secondary Outcomes (4)

  • Change in fasting plasma glucose concentration from baseline to 12 weeks

    Baseline, 12 weeks

  • Change in fasting plasma glucose concentration from baseline to 24 weeks

    Baseline, 24 weeks

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

    Baseline, 12 weeks

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

    Baseline, 24 weeks

Study Arms (2)

Coffee

EXPERIMENTAL

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

Dietary Supplement: Coffee

Placebo

PLACEBO COMPARATOR

Subjects take 4 cups of placebo per day for 24 weeks

Dietary Supplement: Placebo

Interventions

CoffeeDIETARY_SUPPLEMENT
Coffee
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age35 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saw Swee Hock School of Public Health

Singapore, Singapore, 117597, Singapore

Location

Saw Swee Hock School of Public Health

Singapore, 117597, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 31891374DERIVED

  • 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.

    PMID: 29736473DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Coffee

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rob M van Dam

    Saw Swee Hock School of Public Health, National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 23, 2015

Record last verified: 2012-03

Locations

SG(2)