Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

Healthy Clinical Trial

Official title:

Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524550
• Other study ID #: P7573
• Secondary ID: Alcohol Research
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: August 11, 2010
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.

When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.

Description:

Objective:

Primary objectives are to study the effects of moderate alcohol consumption on

• Postprandial insulin secretion and pancreatic beta-cell function

• Physiological and subjective parameters related to satiety and appetite

Secondary objectives are to study the effects of moderate alcohol consumption on

• Miscellaneous markers of glucose homeostasis and insulin sensitivity

• Kinetics of alcohol-induced increase of adiponectin

A tertiary objective is to study the effects of moderate alcohol consumption on

• Gene expression in subcutaneous adipose tissue in normal-weight pre menopausal women with normal fasting plasma glucose.

Study design: Randomized, partially controlled, open label, cross-over study with a one week wash-out preceding each treatment period

Study population: 24 apparently healthy pre menopausal Caucasian women with fasting blood glucose <6.1 mmol/L, aged 20 - 44 years at inclusion of the study, with a BMI of 19 - 25 kg/m2, who use oral contraceptives will participate in the study.

Intervention: Participants will drink daily a test substance for three weeks (2 cans of Amstel beer per day; 66 cL ~ 26 gram alcohol) followed by a reference substance (2 cans of Amstel alcohol-free beer per day; 66 cL < 0.5 gram of alcohol) for three weeks or vice versa. Both treatments are preceded by a one-week wash-out period in which no alcohol is consumed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

• Apparently Females between 20 - 44 years of age

• Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)

• Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L

• Alcohol consumption more or equal then 5 and less than 22 glasses/week

• Body Mass Index (BMI) between 19 and 25 kg/m2

Exclusion Criteria:

• Having the intention to become pregnant, to be pregnant or to lactate during the study

• Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders

• Having a family history of alcoholism

• Smoking

• Reported use of any soft or hard drugs

• Reported unexplained weight loss or gain of > 3 kg in the month prior to the screening

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drinking
• Healthy

Intervention

Dietary Supplement:
• moderate alcohol consumption
drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
TNO

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Joosten MM, Balvers MG, Verhoeckx KC, Hendriks HF, Witkamp RF. Plasma anandamide and other N-acylethanolamines are correlated with their corresponding free fatty acid levels under both fasting and non-fasting conditions in women. Nutr Metab (Lond). 2010 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic beta-cell function		3 weeks of treatment preceded by a 1-week wash-out	No
Primary	Satiety		3 weeks of treatment preceded by a 1-week wash-out	No
Secondary	Kinetics of adiponectin		3 weeks of treatment preceded by a 1-week wash-out	No

External Links

•   publication