MsFLASH02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation

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.