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, Fat and Carbohydrate Metabolism and Insulin Sensitivity

Sponsors

Lead sponsor: TNO

Collaborator: Dutch Foundation for alcohol research

Source TNO
Brief Summary

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

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)

Overall Status Completed
Start Date October 2004
Completion Date December 2004
Primary Completion Date December 2004
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle 4 weeks
Secondary Outcome
Measure Time Frame
Post-prandial glycemic response 4 weeks
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c) 4 weeks
Enrollment 19
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: A

Description: Alcohol consumption (32 g/day) for 4 weeks

Arm group label: A

Intervention type: Dietary Supplement

Intervention name: B

Description: Water

Arm group label: B

Eligibility

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.

Gender: Male

Minimum age: 18 Years

Maximum age: 40 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Henk FJ Hendriks, PhD. Principal Investigator TNO
Verification Date

May 2008

Responsible Party

Name title: Henk Hendriks

Organization: TNO Quality of Life

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Experimental

Description: Whiskey (32 gram of alcohol/day)

Arm group label: B

Arm group type: Placebo Comparator

Description: Water (0 gram alcohol/day)

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov