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Effect of Alcohol on Cephalic Phase Reflex and Gene Expression (AR22)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652405
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : August 11, 2010
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Brief Summary:

Moderate alcohol consumption has consistently been associated with lowered risk of developing type two diabetes mellitus compared to abstainers and heavy drinkers. However, the underlying mechanism for the lower risk of type two diabetes is not clear.

Hypothesis: moderate alcohol consumption for four weeks changes gene expression pathways of inflammatory status, insulin sensitivity and lipid and carbohydrate metabolism in adipose tissue in both lean and obese postmenopausal women.

Hypothesis: Oral sensory stimulation by means of alcohol in the oral cavity will induce a cephalic phase reflex as indicated by increased autonomic & endocrine responses in postmenopausal women.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Inflammation Carbohydrate&Lipid Metabolism Oral Processing Dietary Supplement: alcohol Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Moderate Alcohol Consumption on Cephalic Phase Reflex and Gene Expression of Adipose Tissue in Postmenopausal Women
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: treatment A
four weeks of white wine consumption (25g alcohol/day; ~2.5 standard drinks)
Dietary Supplement: alcohol
250 ml of white wine (13% vol; ~25 gram of alcohol per day)

Placebo Comparator: Treatment B
Four weeks of water
Dietary Supplement: Placebo
250 ml of mineral water (Brand name: Vittel)

Primary Outcome Measures :
  1. Gene expression profiles in adipose tissue [ Time Frame: after four weeks of intervention ]
  2. Pancreatic Polypeptide (PP) [ Time Frame: 0, 4, 8, 12, 16, 20 and 30 min after start of modified sham-feeding with either water, white wine or cake ]

Secondary Outcome Measures :
  1. Cytokines excreted from PBMCs after in vitro stimulation with LPS [ Time Frame: after four weeks of intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 postmenopausal females aged 65 years or younger 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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652405

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TNO Quality of Life
Zeist, Netherlands, 3700AJ
Sponsors and Collaborators
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Principal Investigator: Henk FJ Hendriks, PhD TNO
Publications of Results:
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Responsible Party: Henk Hendriks, TNO Quality of Life Identifier: NCT00652405    
Other Study ID Numbers: P8009
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: May 2008
Keywords provided by TNO:
cephalic phase reflex
gene expression
pancreatic polypeptide
Additional relevant MeSH terms:
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Pathologic Processes