Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2006 |
| End Date: | September 2008 |
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.
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.
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.
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.
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