Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
2 other identifiers
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2006
CompletedFirst Posted
Study publicly available on registry
March 21, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMarch 6, 2018
March 1, 2018
2.3 years
March 20, 2006
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glucose tolerance / insulin sensitivity
4 and 8 weeks
Secondary Outcomes (1)
body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers
4 and 8 weeks
Study Arms (3)
Caffeinated coffee
EXPERIMENTALCaffeinated coffee
Decaffeinated coffee
EXPERIMENTALDecaffeinated coffee
No coffee
ACTIVE COMPARATORInterventions
5 cups per day for 8 weeks
5 cups per day for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (3)
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.
PMID: 21914162RESULTPeter 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.
PMID: 24728416DERIVEDWedick 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.
PMID: 23078574DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rob M van Dam, PhD
Harvard School of Public Health (HSPH)
- PRINCIPAL INVESTIGATOR
Christos Mantzoros, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2006
First Posted
March 21, 2006
Study Start
May 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 6, 2018
Record last verified: 2018-03