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Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00305097
First received: March 20, 2006
Last updated: February 10, 2011
Last verified: February 2011

March 20, 2006
February 10, 2011
March 2006
September 2008   (final data collection date for primary outcome measure)
glucose tolerance / insulin sensitivity [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00305097 on ClinicalTrials.gov Archive Site
body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
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 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Overweight
  • Behavioral: Decaffeinated coffee
    5 cups per day for 8 weeks
    Other Name: Instant Nestle decaffeinated coffee
  • Behavioral: caffeinated coffee
    5 cups per day for 8 weeks
    Other Name: Instant Nestle caffeinated coffee
  • Experimental: 1
    Caffeinated coffee
    Intervention: Behavioral: caffeinated coffee
  • Experimental: 2
    Decaffeinated coffee
    Intervention: Behavioral: Decaffeinated coffee

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
September 2008
September 2008   (final data collection date for primary outcome measure)

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, 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305097
DK46200 (completed), P30 DK46200
No
Rob M. van Dam, Harvard School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Rob M van Dam, PhD Harvard School of Public Health
Principal Investigator: Christos Mantzoros, MD Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP