Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

This study has been completed.
Sponsor:
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00524550
First received: August 30, 2007
Last updated: August 11, 2010
Last verified: May 2008
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: moderate alcohol consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • Pancreatic beta-cell function [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ] [ Designated as safety issue: No ]
  • Satiety [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kinetics of adiponectin [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: moderate alcohol consumption
    drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks
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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524550

Locations
Netherlands
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ
Sponsors and Collaborators
TNO
Investigators
Principal Investigator: Henk FJ Hendriks, PhD Hendriks HFJ
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: henk FJ Hendriks, TNO Quality of life
ClinicalTrials.gov Identifier: NCT00524550     History of Changes
Other Study ID Numbers: P7573, Alcohol Research 21
Study First Received: August 30, 2007
Last Updated: August 11, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO:
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

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Insulin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 22, 2014