Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

NCT ID: NCT00523861

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.

Design: Randomized, partially diet-controlled, placebo controlled cross-over design.

Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).

Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.

Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day

Measures:

* Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
* Gastric emptying and postprandial wellness.
* Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)

Conditions

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Lean Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Moderate alcohol consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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TNO

OTHER

Sponsor Role lead

Principal Investigators

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Henk FJ Hendriks, PhD

Role: PRINCIPAL_INVESTIGATOR

Hendriks HFJ

Locations

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TNO Quality of Life

Zeist, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Alcohol Research 19

Identifier Type: -

Identifier Source: secondary_id

P6281

Identifier Type: -

Identifier Source: org_study_id