Effect of moderate alcohol consumption on postprandial insulin secretion, appetite regulation, glucose homeostasis and insulin resistance.

Completed

Conditions: insuline secretie en eetlust regulatie
- appetite: hunger/satiety

Registration Number: NL-OMON31093

Lead Sponsor: Stichting Alcohol Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Healthy as assessed by the health and lifestyle questionnaire (P7573 F02; in Dutch), physical examination and results of the pre-study laboratory tests
2. Females between 20 - 44 years of age at day of inclusion
3. Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)
4. Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L
5. Used to drink beer
6. Alcohol consumption more or equal than 5 and less than 22 glasses/week
7. Body Mass Index (BMI) between 20 and 25 kg/m2
8. Normal Dutch eating habits as assessed by the questionnaire P7573 F02 on health and lifestyle
9. Appropriate veins for blood sampling and cannula insertion
10. Voluntary participation
11. Having given their written informed consent
12. Willing to comply with the study procedures
13. Willing not to serve as blood donor during the study
14. Non restraint eater, defined as a score of < 3.25 in non obese subjects on the Dutch Eating Behaviour Questionnaire
15. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years

Exclusion Criteria

1. Having the intention to become pregnant, to be pregnant or to lactate during the study
2. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
3. Participation in any non-invasive clinical trial up to 30 days before day 01 of the study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
4. 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
5. Having a family history of alcoholism
6. Mental or physical status that is incompatible with the proper conduct of the study
7. Use of medication that may affect the outcome of the study parameters (except oral contaceptives)
8. Smoking
9. Reported use of any soft or hard drugs
10. Reported unexplained weight loss or gain of > 3 kg in the month prior to the screen¬ing
11. Reported slimming or medically prescribed diet
12. Reported vegetarian, vegan or macrobiotic
13. Recent blood donation (<1 month prior to the start of the study)
14. Not willing to give up blood donation during the study
16. Not having a general practitioner
17. Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from her general practitioner
18. Not willing your general practitioner to be notified upon participation in this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postprandial insulin secretion and pancreatic beta-cell function:<br /><br>For postprandial insulin secretion main parameters are (i)AUC of glucose,<br /><br>C-peptides and insulin after a lunch.<br /><br>Main parameters of pancreatic beta-cell function are glucose sensitivity, rate<br /><br>sensitivity and potentiation (§ 14.3.3). These parameters can be derived from<br /><br>mathematical modelling (P7573 B08). C-peptides, glucose and insulin<br /><br>concentrations will be used as input for the mathematical model.<br /><br><br /><br>Physiological and subjective parameters related to satiety and appetite<br /><br>physiological parameters :of satiety such such as gut hormone concentrations<br /><br>and endocannabinoids<br /><br>subjective measuresof satiety such: subjective ratings of appetite and<br /><br>postprandial wellness (PPW) questions on visual analogue scales (VAS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Miscellaneous markers of glucose homeostasis and insulin sensitivity<br /><br>Concentrations of miscellaneous markers of glucose homeostasis and insulin<br /><br>sensitivity, such as HbA1c, fructosamine, apelin, obestatin, visfatin.<br /><br><br /><br>Kinetics of alcohol-induced increase in adiponectin<br /><br>Adiponectin concentrations at baseline and after one, two and three weeks of<br /><br>treatment.<br /><br><br /><br>Gene expression in subcutaneous adipose tissue<br /><br>mRNA expression of genes corresponding to metabolic pathways involved in<br /><br>glucose and fatty acid metabolism.</p><br>