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Sponsored by: |
TNO Quality of Life |
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Information provided by: | TNO Quality of Life |
ClinicalTrials.gov Identifier: | NCT00652405 |
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 |
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Type 2 Diabetes Inflammation Carbohydrate&Lipid Metabolism Oral Processing |
Dietary Supplement: alcohol Dietary Supplement: Placebo |
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 |
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 |
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treatment A: Experimental
four weeks of white wine consumption (25g alcohol/day; ~2.5 standard drinks)
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Dietary Supplement: alcohol
250 ml of white wine (13% vol; ~25 gram of alcohol per day)
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Treatment B: Placebo Comparator
Four weeks of water
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Dietary Supplement: Placebo
250 ml of mineral water (Brand name: Vittel)
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Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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) |
cephalic phase reflex gene expression inflammation adiponectin pancreatic polypeptide |
Metabolic Diseases Pancreatic Polypeptide Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Metabolic disorder Glucose Metabolism Disorders Alcohol Drinking Ethanol Inflammation |
Pathologic Processes |