Women in Steady Exercise Research (WISER)
- Compare the changes in urine levels of a stable marker of oxidative stress
(F_2-isoprostanes) in healthy young women who undergo exercise training during 4
menstrual cycles vs no exercise.
- Assess the changes in other metabolic factors that explain the association between
physical activity and breast cancer, including:
Estrogen metabolism (estrone, estradiol, estriol, 2-OHE_1, 2-OHE_2, 2-MeOHE_1, 2-MeOHE_2,
4-OHE_1, 4-OHE_2 [as well as ratios of these metabolites], insulin-like growth factor
(IGF)-1 (as well as IGF-binding proteins-1, -2, and -3, insulin, glucose, body composition
(including body mass index, lean mass, and body fat [DEXA scan]).
OUTLINE: This is a randomized, controlled study. Participants are stratified according to
baseline body fat percentage and age (18 to 24 years vs 25 to 30 years). Participants are
randomized to 1 of 2 intervention arms.
- Arm I: Participants exercise for 30 minutes 5 times a week. The intensity of exercise
is increased every 4 weeks. The exercise regimen continues for up to 4 menstrual
- Arm II: Participants are observed for 4 menstrual cycles. Participants in both arms
undergo 24-hour collection of urine on days 7, 8, and 9 of menstrual cycles 1 and 6.
F_2-isoprostanes are measured via gas chromatography-mass spectrometry (GC/MS).
Estrogens are also measured by GC/MS and include E_1, E_2, E_3, 2-OHE_1, 2-OHE_2,
4-OHE_1, 4-OHE_2, 2-MeE_1, 2-MeE_2, 4-MeE_1, 4-MeE_2, and 16OHE_1.
Participants undergo blood collection, body mass measurement by dual-energy x-ray
absorptiometry, and a fitness assessment twice during the 6-month study.
PROJECTED ACCRUAL: A total of 400 participants will be accrued.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Changes in urine levels of F2-isoprostanes
Before and after study
University of Minnesota - Clinical and Translational Science Institute
United States: Institutional Review Board
|University of Minnesota - St. Paul Campus||St. Paul, Minnesota 55108|