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NCT00305097 · ClinicalTrials.gov registry record · NA
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT00305097 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 45 participants.
The verdict
NCT00305097, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Decaffeinated coffee
- DIETARY_SUPPLEMENT Caffeinated coffee
- DIETARY_SUPPLEMENT No coffee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00305097
The ClinicalTrials.gov registry entry for NCT00305097 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Decaffeinated coffee is the first listed.
NCT00305097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00305097 about?
NCT00305097 is a clinical study titled "Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance". 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 ...
What is the current status of trial NCT00305097?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2006-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00305097?
The interventions under investigation include: Decaffeinated coffee (DIETARY_SUPPLEMENT), Caffeinated coffee (DIETARY_SUPPLEMENT), No coffee (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00305097?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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