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OpenTrials
Completed

NCT Number: NCT00364767

Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A

Dietary Supplement

Alcohol consumption (32 g/day) for 4 weeks

B

Dietary Supplement

Water

Primary outcomes

  1. enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle

    Time frame: 4 weeks

Secondary outcomes

  1. Post-prandial glycemic response

    Time frame: 4 weeks

  2. insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

TNO

Other

Collaborators

  • Dutch Foundation for alcohol research

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 16, 2006
Registry last updated
May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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