Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
March 2, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged at least 18 years with an ability and willingness to give written informed consent.
- Body mass index 25-35 kg/m2
- Users of at least 2 cups of caffeinated coffee per day who are willing to be randomized to any of the interventions.
- Non-smoking
Exclusion Criteria:
- 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, Gastroesophageal reflux disease GERD, a history of ulcer, according to a detailed medical history.
- Abnormal hepatic function (liver function test > twice the normal range), abnormal renal function (creatinine > 1.1 mg/dl), fasting plasma glucose in the diabetic range (>/= 126 mg/dl), or blood pressure > 140/90 mmHg.
- Present alcoholism or drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeinated coffee
|
5 cups per day for 8 weeks
Other Names:
|
|
Experimental: Decaffeinated coffee
|
5 cups per day for 8 weeks
Other Names:
|
|
Active Comparator: No coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
glucose tolerance / insulin sensitivity
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christos Mantzoros, MD, Beth Israel Deaconess Medical Center
- Principal Investigator: Rob M van Dam, PhD, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wedick NM, Brennan AM, Sun Q, Hu FB, Mantzoros CS, van Dam RM. Effects of caffeinated and decaffeinated coffee on biological risk factors for type 2 diabetes: a randomized controlled trial. Nutr J. 2011 Sep 13;10:93. doi: 10.1186/1475-2891-10-93.
- Peter PR, Park KH, Huh JY, Wedick NM, Mantzoros CS. Circulating irisin levels are not affected by coffee intake: a randomized controlled trial. PLoS One. 2014 Apr 11;9(4):e94463. doi: 10.1371/journal.pone.0094463. eCollection 2014.
- Wedick NM, Mantzoros CS, Ding EL, Brennan AM, Rosner B, Rimm EB, Hu FB, van Dam RM. The effects of caffeinated and decaffeinated coffee on sex hormone-binding globulin and endogenous sex hormone levels: a randomized controlled trial. Nutr J. 2012 Oct 19;11:86. doi: 10.1186/1475-2891-11-86.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
March 20, 2006
First Submitted That Met QC Criteria
March 20, 2006
First Posted (Estimate)
March 21, 2006
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK46200 (completed)
- P30DK046200 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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