Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
moderate alcohol consumption
Sponsored by

About this trial
This is an interventional prevention trial for Healthy focused on measuring Moderate alcohol consumption, insulin secretion, insulin sensitivity, Beta-cell function, Adiponectin, Appetite, Satiety, Alcohol-induced gene expression, Endocannabinoids, Glucose metabolism, Lipid metabolism, Ratio HMW/total adiponectin, Appetite regulation, Alcohol-induced adiponectin increase
Eligibility Criteria
Inclusion Criteria:
- Apparently Females between 20 - 44 years of age
- Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)
- Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L
- Alcohol consumption more or equal then 5 and less than 22 glasses/week
- Body Mass Index (BMI) between 19 and 25 kg/m2
Exclusion Criteria:
- Having the intention to become pregnant, to be pregnant or to lactate during the study
- Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders
- Having a family history of alcoholism
- Smoking
- Reported use of any soft or hard drugs
- Reported unexplained weight loss or gain of > 3 kg in the month prior to the screening
Sites / Locations
- TNO Quality of Life
Outcomes
Primary Outcome Measures
Pancreatic beta-cell function
Satiety
Secondary Outcome Measures
Kinetics of adiponectin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00524550
Brief Title
Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
Official Title
Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
TNO
4. Oversight
5. Study Description
Brief Summary
A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.
When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.
Detailed Description
Objective:
Primary objectives are to study the effects of moderate alcohol consumption on
Postprandial insulin secretion and pancreatic beta-cell function
Physiological and subjective parameters related to satiety and appetite
Secondary objectives are to study the effects of moderate alcohol consumption on
Miscellaneous markers of glucose homeostasis and insulin sensitivity
Kinetics of alcohol-induced increase of adiponectin
A tertiary objective is to study the effects of moderate alcohol consumption on
Gene expression in subcutaneous adipose tissue in normal-weight pre menopausal women with normal fasting plasma glucose.
Study design: Randomized, partially controlled, open label, cross-over study with a one week wash-out preceding each treatment period
Study population: 24 apparently healthy pre menopausal Caucasian women with fasting blood glucose <6.1 mmol/L, aged 20 - 44 years at inclusion of the study, with a BMI of 19 - 25 kg/m2, who use oral contraceptives will participate in the study.
Intervention: Participants will drink daily a test substance for three weeks (2 cans of Amstel beer per day; 66 cL ~ 26 gram alcohol) followed by a reference substance (2 cans of Amstel alcohol-free beer per day; 66 cL < 0.5 gram of alcohol) for three weeks or vice versa. Both treatments are preceded by a one-week wash-out period in which no alcohol is consumed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Moderate alcohol consumption, insulin secretion, insulin sensitivity, Beta-cell function, Adiponectin, Appetite, Satiety, Alcohol-induced gene expression, Endocannabinoids, Glucose metabolism, Lipid metabolism, Ratio HMW/total adiponectin, Appetite regulation, Alcohol-induced adiponectin increase
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
moderate alcohol consumption
Intervention Description
drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks
Primary Outcome Measure Information:
Title
Pancreatic beta-cell function
Time Frame
3 weeks of treatment preceded by a 1-week wash-out
Title
Satiety
Time Frame
3 weeks of treatment preceded by a 1-week wash-out
Secondary Outcome Measure Information:
Title
Kinetics of adiponectin
Time Frame
3 weeks of treatment preceded by a 1-week wash-out
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Apparently Females between 20 - 44 years of age
Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)
Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L
Alcohol consumption more or equal then 5 and less than 22 glasses/week
Body Mass Index (BMI) between 19 and 25 kg/m2
Exclusion Criteria:
Having the intention to become pregnant, to be pregnant or to lactate during the study
Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders
Having a family history of alcoholism
Smoking
Reported use of any soft or hard drugs
Reported unexplained weight loss or gain of > 3 kg in the month prior to the screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk FJ Hendriks, PhD
Organizational Affiliation
Hendriks HFJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
TNO Quality of Life
City
Zeist
State/Province
Utrecht
ZIP/Postal Code
3700AJ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20546561
Citation
Joosten MM, Balvers MG, Verhoeckx KC, Hendriks HF, Witkamp RF. Plasma anandamide and other N-acylethanolamines are correlated with their corresponding free fatty acid levels under both fasting and non-fasting conditions in women. Nutr Metab (Lond). 2010 Jun 14;7:49. doi: 10.1186/1743-7075-7-49.
Results Reference
result
PubMed Identifier
24548643
Citation
Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.
Results Reference
derived
PubMed Identifier
21353262
Citation
Joosten MM, Witkamp RF, Hendriks HF. Alterations in total and high-molecular-weight adiponectin after 3 weeks of moderate alcohol consumption in premenopausal women. Metabolism. 2011 Aug;60(8):1058-63. doi: 10.1016/j.metabol.2011.01.001. Epub 2011 Feb 24.
Results Reference
derived
Links:
URL
http://www.nutritionandmetabolism.com/content/7/1/49
Description
publication
Learn more about this trial
Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
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