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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decaffeinated coffee
Caffeinated coffee
No coffee
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring coffee, caffeine, glucose tolerance, body weight, insulin sensitivity, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Caffeinated coffee

Decaffeinated coffee

No coffee

Arm Description

Caffeinated coffee

Decaffeinated coffee

Outcomes

Primary Outcome Measures

glucose tolerance / insulin sensitivity

Secondary Outcome Measures

body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers

Full Information

First Posted
March 20, 2006
Last Updated
March 2, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Harvard School of Public Health (HSPH), Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00305097
Brief Title
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
Official Title
Effects of Caffeinated and Decaffeinated Coffee on Body Weight and Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2006 (Actual)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Harvard School of Public Health (HSPH), Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
coffee, caffeine, glucose tolerance, body weight, insulin sensitivity, randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeinated coffee
Arm Type
Experimental
Arm Description
Caffeinated coffee
Arm Title
Decaffeinated coffee
Arm Type
Experimental
Arm Description
Decaffeinated coffee
Arm Title
No coffee
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Decaffeinated coffee
Other Intervention Name(s)
Instant Nestle decaffeinated coffee
Intervention Description
5 cups per day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeinated coffee
Other Intervention Name(s)
Instant Nestle caffeinated coffee
Intervention Description
5 cups per day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
No coffee
Primary Outcome Measure Information:
Title
glucose tolerance / insulin sensitivity
Time Frame
4 and 8 weeks
Secondary Outcome Measure Information:
Title
body weight/fatness, blood pressure, concentrations of blood lipids, adipokines, inflammatory markers
Time Frame
4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob M van Dam, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christos Mantzoros, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21914162
Citation
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.
Results Reference
result
PubMed Identifier
24728416
Citation
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.
Results Reference
derived
PubMed Identifier
23078574
Citation
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.
Results Reference
derived

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

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