Menopause SyndromeGEMLIFENCT05715372
Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy
A study testing Mediterranean diet, AHA walking program and Mindfulness-based stress reduction in people with Menopause Syndrome and Inflammation, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Syndrome, Inflammation, Inflammatory Response
- What is being tested?
- Mediterranean diet, AHA walking program and Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
The long-term goal of this research is to create and implement lifestyle interventions that will prevent or delay morbidities associated with accelerated aging in the menopausal women. By the end of this year, it is estimated that approximately 50 million women will be in the menopausal phase of their life. Menopause is defined by the decline in estrogen levels and subsequent increase in inflammatory markers which are associated with multiple morbidities involving the brain, bone and cardiovascular systems. Various lifestyle changes have been found to prevent or decrease these morbidities. Hormone replacement therapy in the early years of menopause is also a known therapeutic modality for the treatment of menopausal symptoms. The investigators will evaluate if hormone replacement and lifestyle change will have an enhanced effect on the prevention of morbidity and mortality.
Telomeres are distinct structures found at the end of chromosomes. As women enter into menopause, which is the biomarker for aging, there is a shortening of the telomere length. Poor lifestyle factors which cause oxidative stress, can lead to poor cell replication and critical shortening of telomere length. Telomerase, an enzyme which aids in gene sequencing, also declines. Shortened telomere length and low levels of telomerase lead to cell aging and apoptosis, a reduction in normal organ function, and an increase in morbidity and mortality. It has been found that lifestyle intervention, and possibly hormone replacement, can enhance telomere length and telomerase production.
This research will focus on the acute menopausal woman (within 5 years of the last menstrual period), with and without hormone replacement, .and multiple lifestyle interventions. Early intervention within the first five years of menopause is most important in affecting long term morbidity and mortality in women. Serial measurement of various biomarkers and cytokines associated with aging, and measurements of telomere length and telomerase levels will be performed over a 9 month period of time. Evidence shows that diet, physical activity and cognitive intervention may synergize when combined in a multimodal intervention as each targets different mechanisms. The Investigators will evaluate the efficacy of each 12-week interventions on telomere length, telomere production, serum biomarkers and cytokine levels before and after each intervention, and as a multimodal approach. Approximately 100 women will be recruited once they have been confirmed to be in the early stages of menopause, then further divided based on the use of hormone replacement. Aims are to: (1) determine the independent and combined efficacies of lifestyle interventions on telomere length, (2) determine the independent and combined efficacies of lifestyle interventions on biomarkers and and cytokines, (3) Determine other mechanisms of aging associated with the acute phase of menopause . This key knowledge will aid in practical and early lifestyle interventions to deter detrimental morbidities in the menopausal women.
- Conditions
- Menopause Syndrome, Inflammation, Inflammatory Response, Aging, Menopause, Telomere Shortening
- Being tested
- Mediterranean diet, AHA walking program, Mindfulness-based stress reduction, Unstructured Mediterranean diet, Unstructured walking program
- Keywords
- Menopause, Inflammation, Aging, Telomeres, Oxidative Stress, Lifestyle Changes, Mindfulness, Diet, Physical Activity
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
12-week structured program for Mediterranean diet.
AHA walking programBehavioural
12-week structured AHA walking program.
Mindfulness-based stress reductionBehavioural
8-week structured mindfulness-based stress reduction (Cabot).
Unstructured Mediterranean dietBehavioural
Unstructured 12-week program with basic outline for Mediterranean diet.
Unstructured walking programBehavioural
Unstructured 12-week walking program.
Unstructured stress reductionBehavioural
Unstructured program using mobile application for stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group of menopausal women on hormone replacement | Active comparator | This group of women on hormone replacement will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs. Receives: Behavioral: Mediterranean diet; Behavioral: AHA walking program; Behavioral: Mindfulness-based stress reduction |
| Control group of menopausal women on hormone replacement | Placebo comparator | This group of women on hormone replacement will be given unstructured guidelines for diet, physical activity, and stress-reduction. Receives: Behavioral: Unstructured Mediterranean diet; Behavioral: Unstructured walking program; Behavioral: Unstructured stress reduction |
| Intervention group of menopausal women without hormone replacement | Active comparator | This group of women will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs. Receives: Behavioral: Mediterranean diet; Behavioral: AHA walking program; Behavioral: Mindfulness-based stress reduction |
| Control group of menopausal women without hormone replacement | Placebo comparator | This group of women will be given unstructured guidelines for diet, physical activity, and stress-reduction. Receives: Behavioral: Unstructured Mediterranean diet; Behavioral: Unstructured walking program; Behavioral: Unstructured stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Lifestyle Interventions on Telomere Length
Measurement of telomere length after 12 months of a Mediterranean diet, American Heart Association walking program, and mindfulness-based stress reduction program.
Measured: 12 months
Secondary outcomes (2)
Lifestyle Interventions on Inflammatory Biomarkers and Cytokines
Inflammatory biomarkers ( C-Reactive Protein, WBC count) and cytokines (IL-6, TNFa)will be measured before 12 months of Mediterranean diet, the American Heart Association walking program and mindfulness based stress reduction
Measured: 12 months
Measurement of Interventions on Inflammatory Biomarkers and Cytokines
Inflammatory biomarkers C-Reactive Protein, WBC count)after 12 months after a Mediterranean diet, American Heart Association walking program and mindfulness based stress reduction program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start22 Jun 2021
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Why it stopped: no further funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SyndromeStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, single-blinded prospective study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Soltes, MD, Rush University Medical Center
- Investigators
- Barbara Soltes, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715372
- Sponsor's protocol ID
- 20031704
- Acronym
- GEMLIFE
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy
- ClinicalTrials.gov ID
- NCT05715372
- Acronym / sponsor ID
- GEMLIFE / 20031704
- Conditions
- Menopause Syndrome, Inflammation, Inflammatory Response, Aging, Menopause, Telomere Shortening
- Keywords
- Menopause, Inflammation, Aging, Telomeres, Oxidative Stress, Lifestyle Changes, Mindfulness, Diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no further funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long-term goal of this research is to create and implement lifestyle interventions that will prevent or delay morbidities associated with accelerated aging in the menopausal women. By the end of this year, it is estimated that approximately 50 million women will be in the menopausal phase of their life. Menopause is defined by the decline in estrogen levels and subsequent increase in inflammatory markers which are associated with multiple morbidities involving the brain, bone and cardiovascular systems. Various lifestyle changes have been found to prevent or decrease these morbidities. Hormone replacement therapy in the early years of menopause is also a known therapeutic modality for the treatment of menopausal symptoms. The investigators will evaluate if hormone replacement and lifestyle change will have an enhanced effect on the prevention of morbidity and mortality.
Telomeres are distinct structures found at the end of chromosomes. As women enter into menopause, which is the biomarker for aging, there is a shortening of the telomere length. Poor lifestyle factors which cause oxidative stress, can lead to poor cell replication and critical shortening of telomere length. Telomerase, an enzyme which aids in gene sequencing, also declines. Shortened telomere length and low levels of telomerase lead to cell aging and apoptosis, a reduction in normal organ function, and an increase in morbidity and mortality. It has been found that lifestyle intervention, and possibly hormone replacement, can enhance telomere length and telomerase production.
This research will focus on the acute menopausal woman (within 5 years of the last menstrual period), with and without hormone replacement, .and multiple lifestyle interventions. Early intervention within the first five years of menopause is most important in affecting long term morbidity and mortality in women. Serial measurement of various biomarkers and cytokines associated with aging, and measurements of telomere length and telomerase levels will be performed over a 9 month period of time. Evidence shows that diet, physical activity and cognitive intervention may synergize when combined in a multimodal intervention as each targets different mechanisms. The Investigators will evaluate the efficacy of each 12-week interventions on telomere length, telomere production, serum biomarkers and cytokine levels before and after each intervention, and as a multimodal approach. Approximately 100 women will be recruited once they have been confirmed to be in the early stages of menopause, then further divided based on the use of hormone replacement. Aims are to: (1) determine the independent and combined efficacies of lifestyle interventions on telomere length, (2) determine the independent and combined efficacies of lifestyle interventions on biomarkers and and cytokines, (3) Determine other mechanisms of aging associated with the acute phase of menopause . This key knowledge will aid in practical and early lifestyle interventions to deter detrimental morbidities in the menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized, single-blinded prospective study.
| Arm | Type | Receives |
|---|---|---|
| Intervention group of menopausal women on hormone replacement | Active comparator | Behavioral: Mediterranean diet, Behavioral: AHA walking program, Behavioral: Mindfulness-based stress reductionThis group of women on hormone replacement will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs. |
| Control group of menopausal women on hormone replacement | Placebo comparator | Behavioral: Unstructured Mediterranean diet, Behavioral: Unstructured walking program, Behavioral: Unstructured stress reductionThis group of women on hormone replacement will be given unstructured guidelines for diet, physical activity, and stress-reduction. |
| Intervention group of menopausal women without hormone replacement | Active comparator | Behavioral: Mediterranean diet, Behavioral: AHA walking program, Behavioral: Mindfulness-based stress reductionThis group of women will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs. |
| Control group of menopausal women without hormone replacement | Placebo comparator | Behavioral: Unstructured Mediterranean diet, Behavioral: Unstructured walking program, Behavioral: Unstructured stress reductionThis group of women will be given unstructured guidelines for diet, physical activity, and stress-reduction. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet12-week structured program for Mediterranean diet. | Behavioural | Intervention group of menopausal women on hormone replacement, Intervention group of menopausal women without hormone replacement |
| AHA walking program12-week structured AHA walking program. | Behavioural | Intervention group of menopausal women on hormone replacement, Intervention group of menopausal women without hormone replacement |
| Mindfulness-based stress reduction8-week structured mindfulness-based stress reduction (Cabot). | Behavioural | Intervention group of menopausal women on hormone replacement, Intervention group of menopausal women without hormone replacement |
| Unstructured Mediterranean dietUnstructured 12-week program with basic outline for Mediterranean diet. | Behavioural | Control group of menopausal women on hormone replacement, Control group of menopausal women without hormone replacement |
| Unstructured walking programUnstructured 12-week walking program. | Behavioural | Control group of menopausal women on hormone replacement, Control group of menopausal women without hormone replacement |
| Unstructured stress reductionUnstructured program using mobile application for stress reduction. | Behavioural | Control group of menopausal women on hormone replacement, Control group of menopausal women without hormone replacement |
Primary outcome
Independent Lifestyle Interventions on Telomere Length
Time frame: 12 months
Measurement of telomere length after 12 months of a Mediterranean diet, American Heart Association walking program, and mindfulness-based stress reduction program.
2 secondary outcomes
Lifestyle Interventions on Inflammatory Biomarkers and Cytokines
Time frame: 12 months
Measurement of Interventions on Inflammatory Biomarkers and Cytokines
Time frame: 12 months
Results and safety
The study was stopped early (reason given: no further funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Menopause study website-Gem-Life studyLink provided by the sponsor.
- Menopause study social media pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Soltes, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet, AHA walking program and Mindfulness-based stress reduction in people with Menopause Syndrome and Inflammation, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no further funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent Lifestyle Interventions on Telomere Length (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.