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Terminated
NCT05715372
Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy
Conditions: Menopause Syndrome, Inflammation, Inflammatory Response, Aging, Menopause, Telomere Shortening, Stress Oxidative
Sex: Female
Ages: 40 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 5
Sponsor: Rush University Medical Center
Location: United States
Summary
The GEMLIFE Study is a 12-month clinical trial for menopausal women.
The purpose of this study is to promote an improved aging process for women in menopause through lifestyle changes.
The changes will include a heart healthy diet, structured walking program, and mindfulness-based stress reduction.
During the study, the investigators will monitor components of your genetic make-up that will tell us how you are aging.
Investigators will also monitor bloodwork for inflammation that can affect medical conditions.
Study participants may qualify if you are within 5 years of your last menstrual period and have well controlled medical conditions.
There is no cost to participants to enroll in the study- only potential benefits to the participant's health and aging process.
Eligibility Criteria
Inclusion Criteria:Non-hysterectomized women: Amenorrhea > 12 consecutive monthsHysterectomized women: Bilateral oophorectomy (3 months after surgery)Normal mammogram in the past yearNormal pap smear deemed to be negative within 5 yearsAble to understand the protocol and sign an informed consentAble to participate in a structured diet program for 12 weeksAble to participate in a structured walking program for 12 weeksAble to participate in a structured mindfulness-stress reduction programAble to operate an I-PAD, and able to connect to the internetExclusion Criteria:Known or suspected pregnancyUndiagnosed abnormal vaginal bleedingKnown or suspected breast cancer or estrogen-dependent neoplasiaKnown or at risk for a MI, PE or significant cardiovascular eventPoorly controlled blood pressure : sitting systolic > 160 or diastolic >95 mmHgPoorly controlled diabetesUncontrolled thyroid diseaseImpaired liver functionUnstable psychiatric disorder including depression or anxiety, PTSDHistory of drug or alcohol abuseTreatment with anticoagulants ( heparin, warfarin, lovenox, eliquis)Severe systemic disease which might interfere with interpretation of resultsUnwilling or unable to follow a diet, exercise or stress reduction protocol
Source: ClinicalTrials.gov (NCT05715372). StuddyBuddy aggregates publicly available trial information.
