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Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

NCT ID: NCT00364767

Last Updated: 2008-05-23

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2004-12-31

Brief Summary

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Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This association could be mediated by an improvement of insulin sensitivity with moderate alcohol consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This could lead to accumulation triglyceride storage in muscle, which could interfere with insulin signaling. Whether such mechanism can also play a role with moderate alcohol consumption is unknown and will be investigated in this study.

In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic response in healthy subjects is unknown. This is a secondary objective of this trial.

Detailed Description

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To investigate the effect of moderate alcohol consumption on

* enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
* transporters of fatty acids and glucose in fat tissue
* post-prandial glycemic response in healthy, lean or overweight, young men

Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design

Participants

* Description : Healthy, lean and overweight young (18-40 years) men
* Number : 20

Study substances

* Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)
* Reference substance : 100 ml mineral water (Spa blauw)

Duration: 2 treatment periods of 4 weeks (28 days)

Test parameters:

* Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase, cytochrome c oxidase
* Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.)
* Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin, HbA1c)
* Liver enzymes (safety)
* Body weight
* Urinary ethyl glucuronide (compliance)

Conditions

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Diabetes Mellitus, Type 2 Cardiovascular Disease

Keywords

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Moderate alcohol consumption Fat and carbohydrate oxidative capacity Postprandial glycemic response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Whiskey (32 gram of alcohol/day)

Group Type EXPERIMENTAL

A

Intervention Type DIETARY_SUPPLEMENT

Alcohol consumption (32 g/day) for 4 weeks

B

Water (0 gram alcohol/day)

Group Type PLACEBO_COMPARATOR

B

Intervention Type DIETARY_SUPPLEMENT

Water

Interventions

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A

Alcohol consumption (32 g/day) for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

B

Water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy men aged between 18 and 40 years
* Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI \>27 kg/m2 (including 18.5, 25 and 27)
* Alcohol consumption between 7 and 28 units/week (including 7 and 28)

Exclusion Criteria

* Smoking
* Family history of alcoholism
* History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
* Recent blood donation
* More than 8 hours/week of intense exercise
* Blood haemoglobin concentration below 8.4 mmol/l
* Allergic to betadine or lidocaine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dutch Foundation for alcohol research

UNKNOWN

Sponsor Role collaborator

TNO

OTHER

Sponsor Role lead

Responsible Party

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TNO Quality of Life

Principal Investigators

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Henk FJ Hendriks, PhD.

Role: PRINCIPAL_INVESTIGATOR

TNO

References

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Beulens JW, van Loon LJ, Kok FJ, Pelsers M, Bobbert T, Spranger J, Helander A, Hendriks HF. The effect of moderate alcohol consumption on adiponectin oligomers and muscle oxidative capacity: a human intervention study. Diabetologia. 2007 Jul;50(7):1388-92. doi: 10.1007/s00125-007-0699-8. Epub 2007 May 11.

Reference Type RESULT
PMID: 17492425 (View on PubMed)

Other Identifiers

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P5805

Identifier Type: -

Identifier Source: org_study_id