Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

August 11, 2010 updated by: TNO

Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Zeist, Utrecht, Netherlands, 3700AJ
        • TNO Quality of Life

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pancreatic beta-cell function
Time Frame: 3 weeks of treatment preceded by a 1-week wash-out
3 weeks of treatment preceded by a 1-week wash-out
Satiety
Time Frame: 3 weeks of treatment preceded by a 1-week wash-out
3 weeks of treatment preceded by a 1-week wash-out

Secondary Outcome Measures

Outcome Measure
Time Frame
Kinetics of adiponectin
Time Frame: 3 weeks of treatment preceded by a 1-week wash-out
3 weeks of treatment preceded by a 1-week wash-out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Investigators

  • Principal Investigator: Henk FJ Hendriks, PhD, Hendriks HFJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P7573
  • Alcohol Research 21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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