Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance

Summary

Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism according to recent findings of epidemiological studies in the U.S., Europe, and Japan. However, data from longer-term human intervention studies with appropriate outcome measures are lacking. We will study the effects of caffeinated and decaffeinated coffee consumption on body fatness, insulin sensitivity and glucose tolerance that may underlie the observed associations with a lower risk of type 2 diabetes in a randomized controlled trial. We hypothesize that both caffeinated and decaffeinated coffee will improve insulin sensitivity and glucose tolerance. Before starting a larger, long-term intervention study, we will conduct a pilot study to test the feasibility of such a trial. The pilot study will be an 8-week parallel trial in 45 overweight individuals, who will be randomized to drinking 5 cups per day of 1) caffeinated coffee (n=15), 2) decaffeinated coffee (n=15), or 3) water (n=15). Body fatness (weight, waist circumference, bioelectrical impedance), insulin sensitivity (HOMA model), and glucose tolerance (oral glucose tolerance test) will be the primary outcomes. We will assess the adherence of participants to their assigned treatment by measuring serum caffeine concentrations, documentation of coffee use in diaries by the participants, and counting unused coffee packets. We will also obtain feedback from participants on how to improve compliance in a future trial. If successful, this study will form the basis for a definitive trial of coffee consumption, body fatness, and glucose tolerance. Given the extensive use of coffee and the rapidly increasing health burden of type 2 diabetes, such a trial would have important public health implications.

Conditions

• Overweight

Interventions

DIETARY_SUPPLEMENT

Decaffeinated coffee

5 cups per day for 8 weeks

DIETARY_SUPPLEMENT

Caffeinated coffee

5 cups per day for 8 weeks

DIETARY_SUPPLEMENT

No coffee

Sponsors & Collaborators

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Rob M van Dam, PhD · Harvard School of Public Health (HSPH)

• Christos Mantzoros, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• United States

Study Locations