Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying - Full Text View

Sponsored by:	TNO Quality of Life
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00523861

Purpose

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	Intervention
Lean Obese	Dietary Supplement: Moderate alcohol consumption

MedlinePlus related topics: Alcohol

Drug Information available for: Ethanol Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title:	The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men

Further study details as provided by TNO Quality of Life:

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 [ Time Frame: 3 weeks ]

Secondary Outcome Measures:

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

Enrollment:	17
Study Start Date:	May 2005
Study Completion Date:	June 2005

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)

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male

Criteria

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

Exclusion Criteria:

Smoking
Not willing or able to change habitual alcohol consumption during the study according to protocol
Having an allergy for paracetamol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523861

Locations

Netherlands, Utrecht
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ

Sponsors and Collaborators

TNO Quality of Life

Investigators

Principal Investigator:

Henk FJ Hendriks, PhD

Hendriks HFJ

More Information

No publications provided

Study ID Numbers:	P6281, Alcohol Research 19
Study First Received:	August 30, 2007
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00523861 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO Quality of Life:

Glucose
Insulin sensitivity
Glucose metabolism
Appetite
Satiety

Study placed in the following topic categories:

Obesity
Drinking Behavior
Overweight
Healthy

Alcohol Drinking
Insulin
Ethanol

Additional relevant MeSH terms:

Drinking Behavior
Alcohol Drinking

ClinicalTrials.gov processed this record on May 07, 2009