Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

May 22, 2008 updated by: TNO

The Effect of Moderate Alcohol Consumption on Markers of Oxidative Phosphorylation and Lipid Oxidation and on Postprandial Glycemic Control in Healthy, Lean and Overweight, Young Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Whiskey (32 gram of alcohol/day)
Dietary supplement: A
Alcohol consumption (32 g/day) for 4 weeks
Placebo Comparator: B
Water (0 gram alcohol/day)
Dietary supplement: B
Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-prandial glycemic response
Time Frame: 4 weeks
4 weeks
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Collaborators

Dutch Foundation for alcohol research

Investigators

  • Principal Investigator: Henk FJ Hendriks, PhD., TNO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

August 15, 2006

First Submitted That Met QC Criteria

August 15, 2006

First Posted (Estimate)

August 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 23, 2008

Last Update Submitted That Met QC Criteria

May 22, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P5805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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