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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014