Effect of moderate alcohol consumption on cephalic phase reflex and gene expression of adipose tissue in postmenopausal wome

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Healthy as assessed by the health and lifestyle questionnaire (P8009 F02), physical examination and results of the pre-study laboratory tests
2. Caucasian females aged > 46 and * 65 years at Day 01 of the study.
3. Body Mass Index (BMI) of 18 - 26 or 27 - 35 kg/m2.
4. Postmenopausal as assessed by self reported absence of menstrual periods for at least 12 months.
5. Alcohol consumption >= 5 and <= 22 standard units/week.
6. Normal Dutch eating habits as assessed by P8009 F02.
7. Voluntary participation.
8. Having given written informed consent.
9. Willing to comply with the study procedures, including refrain from drinking alcoholic drinks other then the wine provided by TNO during the entire study.
10. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
11. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion Criteria

Subjects with one or more of the following characteristics will be excluded from participation:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances.
3. Having a history of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disease and gastrointestinal disorders.
4. Use of medication that may affect the outcome of the study parameters.
5. Having a family history of alcoholism.
6. Smoking.
7. Not having appropriate veins for blood sampling/cannula insertion according to TNO.
8. Reported unexplained weight loss or gain in the month prior to the pre-study screening.
9. Reported slimming or medically prescribed diet.
10. Reported vegan, vegetarian or macrobiotic.
11. Recent blood donation (<1 month prior to the start of the study).
12. Not willing to give up blood donation during the study.
13. Personnel of TNO Quality of Life, their partner and their first and second degree relatives.
14. Not having a general practitioner.
15. 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 his general practitioner.
16. 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>Cephalic phase reflex:<br /><br>Pancreatic polypeptide (PP) in serum.<br /><br>Gene expression in adipose tissue:<br /><br>Gene expression pathways related to inflammation, insulin sensitivity<br /><br>and lipid and carbohydrate metabolism in subcutaneous adipose tissue</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Markers of inflammation, insulin sensitivity and lipid metabolism:<br /><br>- Adiponectin (both total and HMW) and cytokines in plasma;<br /><br>- Cytokines excreted from Peripheral Blood Mononuclear Cells (PBMC)<br /><br>after<br /><br>in vitro stimulation with inflammatory agents.</p><br>