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Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

This study has been completed.
Sponsor:
Collaborator:
Dutch Foundation for alcohol research
Information provided by:
TNO Quality of Life
ClinicalTrials.gov Identifier:
NCT00364767
First received: August 15, 2006
Last updated: May 22, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Cardiovascular Disease
 Dietary Supplement: A
Dietary Supplement: B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TNO Quality of Life:

Primary Outcome Measures:
  • enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-prandial glycemic response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: October 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364767

Sponsors and Collaborators
TNO Quality of Life
Dutch Foundation for alcohol research
Investigators
Principal Investigator: Henk FJ Hendriks, PhD. TNO Quality of Life
  More Information

Publications:

Responsible Party: Henk Hendriks, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT00364767     History of Changes
Other Study ID Numbers: P5805
Study First Received: August 15, 2006
Last Updated: May 22, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO Quality of Life:
Moderate alcohol consumption
Fat and carbohydrate oxidative capacity
Postprandial glycemic response

Additional relevant MeSH terms:
Alcohol Drinking
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Drinking Behavior
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013