Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00652405
First received: March 31, 2008
Last updated: August 10, 2010
Last verified: May 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • Gene expression profiles in adipose tissue [ Time Frame: after four weeks of intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytokines excreted from PBMCs after in vitro stimulation with LPS [ Time Frame: after four weeks of intervention ] [ Designated as safety issue: No ]

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

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
TNO Quality of Life
Zeist, Netherlands, 3700AJ
Sponsors and Collaborators
TNO
Investigators
Principal Investigator: Henk FJ Hendriks, PhD TNO
  More Information

Publications:
Responsible Party: Henk Hendriks, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT00652405     History of Changes
Other Study ID Numbers: P8009
Study First Received: March 31, 2008
Last Updated: August 10, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO:
cephalic phase reflex
gene expression
inflammation
adiponectin
pancreatic polypeptide

Additional relevant MeSH terms:
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus, Type 2
Inflammation
Diabetes Mellitus
Pathologic Processes
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014