NCT00523861

Brief Summary

Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.2 years 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
Last Updated

September 14, 2007

Status Verified

August 1, 2007

First QC Date

August 30, 2007

Last Update Submit

September 10, 2007

Conditions

LeanObese

Keywords

GlucoseInsulin sensitivityGlucose metabolismAppetiteSatiety

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage

    3 weeks

Secondary Outcomes (1)

  • Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.

    3 weeks

Interventions

Moderate alcohol consumptionDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy as assessed by the:
  • physical examination
  • results of the pre-study laboratory tests
  • Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
  • Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
  • Alcohol consumption between 7 and 28 units/week (including 7 and 28)
  • Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire

You may not qualify if:

  • Smoking
  • Not willing or able to change habitual alcohol consumption during the study according to protocol
  • Having an allergy for paracetamol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3700AJ, Netherlands

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

EthanolEconomics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic 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
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

May 1, 2005

Study Completion

June 1, 2005

Last Updated

September 14, 2007

Record last verified: 2007-08

Locations

NL(1)