NCT00524550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 12, 2010

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

August 30, 2007

Last Update Submit

August 11, 2010

Conditions

Healthy

Keywords

Moderate alcohol consumptioninsulin secretioninsulin sensitivityBeta-cell functionAdiponectinAppetiteSatietyAlcohol-induced gene expressionEndocannabinoidsGlucose metabolismLipid metabolismRatio HMW/total adiponectinAppetite regulationAlcohol-induced adiponectin increase

Outcome Measures

Primary Outcomes (2)

  • Pancreatic beta-cell function

    3 weeks of treatment preceded by a 1-week wash-out

  • Satiety

    3 weeks of treatment preceded by a 1-week wash-out

Secondary Outcomes (1)

  • Kinetics of adiponectin

    3 weeks of treatment preceded by a 1-week wash-out

Interventions

moderate alcohol consumptionDIETARY_SUPPLEMENT

drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3700AJ, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 20546561RESULT

  • 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.

    PMID: 24548643DERIVED

  • 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.

    PMID: 21353262DERIVED

Related Links

MeSH Terms

Conditions

Insulin Resistance

Interventions

EthanolEconomics

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHealth Care Economics and Organizations

Study Officials

  • Henk FJ Hendriks, PhD

    Hendriks HFJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 12, 2010

Record last verified: 2008-05

Locations

NL(1)