Effect of Alcohol on Cephalic Phase Reflex and Gene Expression - Full Text View

Sponsored by:	TNO Quality of Life
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00652405

Purpose

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	Intervention
Type 2 Diabetes Inflammation Carbohydrate&Lipid Metabolism Oral Processing	Dietary Supplement: alcohol Dietary Supplement: Placebo

MedlinePlus related topics: Alcohol Consumption Diabetes Dietary Supplements

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title:	Effect of Moderate Alcohol Consumption on Cephalic Phase Reflex and Gene Expression of Adipose Tissue in Postmenopausal Women

Further study details as provided by TNO Quality of Life:

Primary Outcome Measures:

Gene expression pathways related to inflammation, insulin sensitivity and lipid and carbohydrate metabolism in subcutaneous adipose tissue [ Time Frame: after four weeks of intervention ] [ Designated as safety issue: No ]
Pancreatic Polypeptide (PP). [ Time Frame: after modified sham-feeding of wine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cytokines excreted from PBMCs after in vitro stimulation with inflammatory agents [ Time Frame: after four weeks of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
treatment A: Experimental 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)
Treatment B: Placebo Comparator Four weeks of water	Dietary Supplement: Placebo 250 ml of mineral water (Brand name: Vittel)

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Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
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.
Having a history of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disease and gastrointestinal disorders.
Use of medication that may affect the outcome of the study parameters.
Having a family history of alcoholism.
Smoking.
Not having appropriate veins for blood sampling/cannula insertion according to TNO.
Reported unexplained weight loss or gain in the month prior to the pre-study screening.
Reported slimming or medically prescribed diet.
Reported vegan, vegetarian or macrobiotic.
Recent blood donation (<1 month prior to the start of the study).
Not willing to give up blood donation during the study.
Personnel of TNO Quality of Life, their partner and their first and second degree relatives.
Not having a general practitioner.
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.
Not willing your general practitioner to be notified upon participation in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652405

Locations

Netherlands
TNO Quality of Life
Zeist, Netherlands, 3700AJ

Sponsors and Collaborators

TNO Quality of Life

Investigators

Principal Investigator:

Henk FJ Hendriks, PhD

TNO Quality of Life

More Information

Responsible Party:	TNO Quality of Life ( Henk Hendriks )
Study ID Numbers:	P8009
Study First Received:	March 31, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00652405
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO Quality of Life:

cephalic phase reflex
gene expression
inflammation
adiponectin
pancreatic polypeptide

Study placed in the following topic categories:

Metabolic Diseases
Pancreatic Polypeptide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Alcohol Drinking
Ethanol
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009