MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation

This is an interventional treatment trial for Hot Flashes focused on measuring Hot Flashes, Menopause, Vasomotor symptoms, Yoga, Exercise, Omega-3, Fish oil Read More

Inclusion Criteria:

• Females aged 40-62 years.

• Menopausal, including:

  • Women who have had a bi-lateral oophorectomy;
  • Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval of 60 or more days in the past 12 months;
  • Women without a uterus and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL;
  • Women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL.
• Having bothersome hot flashes and/or night sweats.

• In general good health as determined by medical history, blood pressure, and heart rate:

  • Absence of uncontrolled hypertension greater than 160/100;
  • Resting heart rate less than 110 beats per minute;.
  • No history of myocardial infarction, angina, or cerebrovascular events;.
  • No history of liver, renal disease, or uncontrolled seizure disorder.
  • Absence of uncontrolled metabolic disease (such as diabetes) and absence of current infectious disease (such as acute symptoms of mononucleosis) that would put staff and other participants at risk.
• Signed informed consent.

Exclusion Criteria:

• Use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD) during the 2 months before enrollment. Vaginal postmenopausal estrogens allowed, with the exception of vaginal creams used more than 3 times a week.
• Use of any other therapy that is taken specifically for hot flashes, including prescription, over-the-counter, or herbal therapies, in the past month.
• Any current severe or unstable medical illness.
• Body mass index (BMI) of 37 or higher, based on measured height and weight.
• Severe uncorrected hearing or vision problems.
• Current, regular use of anti-coagulants 3 or more times per week, e.g. Coumadin, Heparin, Clopidogrel, aspirin at full dose (due to possible omega-3 supplement interaction).
• Drug or alcohol abuse in the past 1 year.
• Major severe depressive episode in the past 3 months.
• Diagnosis of psychosis or psychotic disorder.
• Pregnancy, intending pregnancy, or breastfeeding.
• Current participation in another drug trial or intervention study.
• Inability or unwillingness to complete the study procedures or interventions.

• Physical limitations that limit the ability to participate in yoga or exercise, for example:

  • Limited mobility (paralyzed, cannot walk 2 blocks);
  • Back problems (severe spine abnormality, sciatica, prior back surgery, spine fracture in the past 3 months);
  • musculoskeletal problems that limit the ability to walk on a treadmill or ride a stationary bicycle;
• Presence of any absolute contraindications to exercise testing and training, as defined by the American College of Sports Medicine.

• Practiced or attended any of the following in the prior 3 months:

  • Yoga, tai chi, qi gong, or meditation more than one time per week on average;
  • Aerobic exercise (more than 30 minutes a day on at least 3 days a week);
  • Inability to achieve 85% of heart rate reserve (HRR; the difference between maximum heart rate and resting heart rate) on graded exercise treadmill test.
• Severe allergy to soy (defined as life-threatening reaction to soy that would require medical intervention).
• Allergy or sensitivity to fish.
• Currently eating 4 or more servings of fish per week.
• Currently taking an omega-3 fish oil supplement more than twice per week in the past 4 weeks and unwilling to stop for 12 weeks. Interest women can stop all omega-3 supplements and reevaluate eligibility 4 weeks after stopping the omega-3 supplements.