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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK046200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeinated coffee | Experimental | Caffeinated coffee |
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| Decaffeinated coffee | Experimental | Decaffeinated coffee |
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| No coffee | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decaffeinated coffee | Dietary Supplement | 5 cups per day for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| glucose tolerance / insulin sensitivity | 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers | 4 and 8 weeks |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob M van Dam, PhD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Christos Mantzoros, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21914162 | Result | 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. | |
| 24728416 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D001835 | Body Weight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Caffeinated coffee | Dietary Supplement | 5 cups per day for 8 weeks |
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| No coffee | Dietary Supplement |
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| 23078574 | Derived | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |