Effect of PPARγ2 Polymorphism and NSAIDs on Acute Alcohol-induced Changes in Serum Estrogens Among Post-menopausal Women

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Professor Lars Ove Dragsted
• Collaborator: Technical University of Denmark
• Treatments: Estrogens; Ethanol; Ibuprofen

Criteria

Inclusion Criteria:

1. postmenopausal (last menses at least 1 year earlier);

2. having a weekly alcohol use of less than 14 drinks

3. having a BMI of 18-35;

Exclusion Criteria:

1. a history of alcohol abuse

2. alcohol abstaining

3. history of hysterectomy before last menses with preservation of both ovaries (unless a medical confirmation for the postmenopausal status exists or the participant is 60 years or older);

4. major health problems, such as ulcers, heart diseases, diabetes or cancer

5. previous or current use of HRT

6. taking prescription medications that could interfere with the study (i.e. daily use of NSAIDs and/or medication that interact with PPARγ e.g. cholesterol lowering medicine);

7. being allergic to alcohol and/or Ibuprofen

8. smoking