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CompletedNCT00364767Updated May 23, 2008

Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

An interventional study of A and B in Diabetes Mellitus, Type 2 and Cardiovascular Disease, sponsored by TNO. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-23.

Sponsored by TNO · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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)
02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Cardiovascular Disease

Keywords

  • Moderate alcohol consumption
  • Fat and carbohydrate oxidative capacity
  • Postprandial glycemic response
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 19 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

TNO is the lead sponsor of 31 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    A

    Whiskey (32 gram of alcohol/day)

    Dietary Supplement: A

  • Placebo comparator
    B

    Water (0 gram alcohol/day)

    Dietary Supplement: B

Interventions

  • Dietary supplementA

    Alcohol consumption (32 g/day) for 4 weeks

  • Dietary supplementB

    Water

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Beulens JW, van Loon LJ, Kok FJ, Pelsers M, Bobbert T, Spranger J, Helander A, Hendriks HF. The effect of moderate alcohol consumption on adiponectin oligomers and muscle oxidative capacity: a human intervention study. Diabetologia. 2007 Jul;50(7):1388-92. doi: 10.1007/s00125-007-0699-8. Epub 2007 May 11. PubMed 17492425 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00364767
Lead sponsor
TNO
Collaborators
Dutch Foundation for alcohol research
First posted
Aug 16, 2006
Start date
Oct 2004
Primary completion
Dec 2004
Completion
Dec 2004
Last update
May 23, 2008

Study contacts

Henk FJ Hendriks, PhD.
principal investigator · TNO

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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