Effect of Alcohol on Cephalic Phase Reflex and Gene Expression

NCT00652405 | Completed DMC

• 1 other identifier: P8009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Inflammation; Carbohydrate&Lipid Metabolism; Oral Processing

Keywords

cephalic phase reflex; gene expression; inflammation; adiponectin; pancreatic polypeptide

Outcome Measures

Primary Outcomes (2)

• Gene expression profiles in adipose tissue

  after four weeks of intervention

• Pancreatic Polypeptide (PP)

  0, 4, 8, 12, 16, 20 and 30 min after start of modified sham-feeding with either water, white wine or cake

Secondary Outcomes (1)

• Cytokines excreted from PBMCs after in vitro stimulation with LPS

  after four weeks of intervention

Study Arms (2)

treatment A

EXPERIMENTAL

four weeks of white wine consumption (25g alcohol/day; \~2.5 standard drinks)

Dietary Supplement: alcohol

Treatment B

PLACEBO COMPARATOR

Four weeks of water

Dietary Supplement: Placebo

Interventions

alcohol DIETARY_SUPPLEMENT

250 ml of white wine (13% vol; \~25 gram of alcohol per day)

treatment A

Placebo DIETARY_SUPPLEMENT

250 ml of mineral water (Brand name: Vittel)

Treatment B

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead

Study Sites (1)

TNO Quality of Life

Zeist, 3700AJ, Netherlands

Location

Related Publications (2)

• Joosten MM, Balvers MG, Verhoeckx KC, Hendriks HF, Witkamp RF. Plasma anandamide and other N-acylethanolamines are correlated with their corresponding free fatty acid levels under both fasting and non-fasting conditions in women. Nutr Metab (Lond). 2010 Jun 14;7:49. doi: 10.1186/1743-7075-7-49.

  PMID: 20546561 RESULT

• Joosten MM, de Graaf C, Rietman A, Witkamp RF, Hendriks HF. Short-term oral exposure to white wine transiently lowers serum free fatty acids. Appetite. 2010 Aug;55(1):124-9. doi: 10.1016/j.appet.2010.04.217. Epub 2010 May 11.

  PMID: 20438782 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Henk FJ Hendriks, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 11, 2010

Record last verified: 2008-05

Locations

NL (1)