Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305097
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2006-03-20
Brief Title:
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism according to recent findings of epidemiological studies in the US 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 n15 2 decaffeinated coffee n15 or 3 water n15 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
Detailed Description:
Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism according to recent findings of epidemiological studies in the US 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 n15 2 decaffeinated coffee n15 or 3 water n15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30DK046200 | NIH | None | httpsreporternihgovquickSearchP30DK046200 |