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NCT Number: NCT00524550

Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

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.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TNO Quality of Life

Zeist, Utrecht, 3700AJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moderate alcohol consumption

Dietary Supplement

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

Primary outcomes

  1. Pancreatic beta-cell function

    Time frame: 3 weeks of treatment preceded by a 1-week wash-out

  2. Satiety

    Time frame: 3 weeks of treatment preceded by a 1-week wash-out

Secondary outcomes

  1. Kinetics of adiponectin

    Time frame: 3 weeks of treatment preceded by a 1-week wash-out

Sponsors and collaborators

Lead sponsor

TNO

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 3, 2007
Registry last updated
Aug 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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