Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy (NCT05715372) | Clinical Trial Compass
TerminatedNot Applicable
Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy
Stopped: no further funding
United States5 participantsStarted 2021-06-22
Plain-language 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.
Who can participate
Age range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-hysterectomized women: Amenorrhea \> 12 consecutive months
* Hysterectomized women: Bilateral oophorectomy (3 months after surgery)
* Normal mammogram in the past year
* Normal pap smear deemed to be negative within 5 years
* Able to understand the protocol and sign an informed consent
* Able to participate in a structured diet program for 12 weeks
* Able to participate in a structured walking program for 12 weeks
* Able to participate in a structured mindfulness-stress reduction program
* Able to operate an I-PAD, and able to connect to the internet
Exclusion Criteria:
* Known or suspected pregnancy
* Undiagnosed abnormal vaginal bleeding
* Known or suspected breast cancer or estrogen-dependent neoplasia
* Known or at risk for a MI, PE or significant cardiovascular event
* Poorly controlled blood pressure : sitting systolic \> 160 or diastolic \>95 mmHg
* Poorly controlled diabetes
* Uncontrolled thyroid disease
* Impaired liver function
* Unstable psychiatric disorder including depression or anxiety, PTSD
* History of drug or alcohol abuse
* Treatment with anticoagulants ( heparin, warfarin, lovenox, eliquis)
* Severe systemic disease which might interfere with interpretation of results
* Unwilling or unable to follow a diet, exercise or stress reduction protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Independent Lifestyle Interventions on Telomere Length