Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

Sponsor

TNO (Other)

Overall Status

Completed

CT.gov ID

NCT00523861

Collaborator

(none)

Enrollment

Location

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

Condition or Disease	Intervention/Treatment	Phase
Lean Obese	Dietary Supplement: Moderate alcohol consumption	N/A

Detailed Description

Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.

Design: Randomized, partially diet-controlled, placebo controlled cross-over design.

Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).

Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.

Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day

Measures:

Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
Gastric emptying and postprandial wellness.
Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men

Study Start Date :

May 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage [3 weeks]

Secondary Outcome Measures

Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Inclusion Criteria:

Healthy as assessed by the:
physical examination
results of the pre-study laboratory tests
Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
Alcohol consumption between 7 and 28 units/week (including 7 and 28)
Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire