Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

NCT ID: NCT00524550

Last Updated: 2010-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-11-30

Brief 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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

moderate alcohol consumption

drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TNO

OTHER

Sponsor Role: lead

Responsible Party

TNO Quality of life

Principal Investigators

Henk FJ Hendriks, PhD

Role: PRINCIPAL_INVESTIGATOR

Hendriks HFJ

Locations

TNO Quality of Life

Zeist, Utrecht, Netherlands

Countries

Netherlands

References

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 Jun 14;7:49. doi: 10.1186/1743-7075-7-49.

Reference Type: RESULT

PMID: 20546561 (View on PubMed)

Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.

Reference Type: DERIVED

PMID: 24548643 (View on PubMed)

Joosten MM, Witkamp RF, Hendriks HF. Alterations in total and high-molecular-weight adiponectin after 3 weeks of moderate alcohol consumption in premenopausal women. Metabolism. 2011 Aug;60(8):1058-63. doi: 10.1016/j.metabol.2011.01.001. Epub 2011 Feb 24.

Reference Type: DERIVED

PMID: 21353262 (View on PubMed)

Related Links

http://www.nutritionandmetabolism.com/content/7/1/49

publication

Other Identifiers

Alcohol Research 21

Identifier Type: -

Identifier Source: secondary_id

P7573

Identifier Type: -

Identifier Source: org_study_id