Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Cardiovascular Disease
• Interventions: Dietary Supplement: A; Dietary Supplement: B

• Registration Number: NCT00364767
• Lead Sponsor: 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)

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2006-08-15
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-16
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-22
• Last Update Posted: 2008-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	A	Whiskey (32 gram of alcohol/day)
B	B	Water (0 gram alcohol/day)

Primary Outcome Measures

Name	Time	Method
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle	4 weeks

Secondary Outcome Measures

Name	Time	Method
Post-prandial glycemic response	4 weeks
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)	4 weeks