We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364767
First Posted: August 16, 2006
Last Update Posted: May 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dutch Foundation for alcohol research
Information provided by:
TNO
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by TNO:

Primary Outcome Measures:
  • enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle [ Time Frame: 4 weeks ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364767


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

Publications:
Responsible Party: Henk Hendriks, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT00364767     History of Changes
Other Study ID Numbers: P5805
First Submitted: August 15, 2006
First Posted: August 16, 2006
Last Update Posted: May 23, 2008
Last Verified: May 2008

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

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