Trial | NCT00364767  Report issue

Title

Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity
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

  • Phase

    N/A

  • Lead Sponsor

    TNO

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
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.
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 Started
Oct 31
2004
Primary Completion
Dec 31
2004
Study Completion
Dec 31
2004
Last Update
May 23
2008
Estimate

Dietary Supplement A [pertuzumab (perjeta), paclitaxel (taxol), carboplatin (paraplatin), trastuzumab (herceptin)]

Alcohol consumption (32 g/day) for 4 weeks

Dietary Supplement B

Water

A Experimental

Whiskey (32 gram of alcohol/day)

  • Dietary Supplement A

B Placebo Comparator

Water (0 gram alcohol/day)

  • Dietary Supplement B

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.
No Results Posted