Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy (GEMLIFE)

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Inflammatory Response; Menopause; Aging; Telomere Shortening; Menopause Syndrome; Stress Oxidative
• Intervention / Treatment: Behavioral: Mediterranean diet; Behavioral: AHA walking program; Behavioral: Mindfulness-based stress reduction; Behavioral: Unstructured Mediterranean diet; Behavioral: Unstructured walking program; Behavioral: Unstructured stress reduction

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group of menopausal women on hormone replacement; This group of women on hormone replacement will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs.	Behavioral: Mediterranean diet; 12-week structured program for Mediterranean diet.; Behavioral: AHA walking program; 12-week structured AHA walking program.; Behavioral: Mindfulness-based stress reduction; 8-week structured mindfulness-based stress reduction (Cabot).
PLACEBO_COMPARATOR: Control group of menopausal women on hormone replacement; This group of women on hormone replacement will be given unstructured guidelines for diet, physical activity, and stress-reduction.	Behavioral: Unstructured Mediterranean diet; Unstructured 12-week program with basic outline for Mediterranean diet.; Behavioral: Unstructured walking program; Unstructured 12-week walking program.; Behavioral: Unstructured stress reduction; Unstructured program using mobile application for stress reduction.
ACTIVE_COMPARATOR: Intervention group of menopausal women without hormone replacement; This group of women will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs.	Behavioral: Mediterranean diet; 12-week structured program for Mediterranean diet.; Behavioral: AHA walking program; 12-week structured AHA walking program.; Behavioral: Mindfulness-based stress reduction; 8-week structured mindfulness-based stress reduction (Cabot).
PLACEBO_COMPARATOR: Control group of menopausal women without hormone replacement; This group of women will be given unstructured guidelines for diet, physical activity, and stress-reduction.	Behavioral: Unstructured Mediterranean diet; Unstructured 12-week program with basic outline for Mediterranean diet.; Behavioral: Unstructured walking program; Unstructured 12-week walking program.; Behavioral: Unstructured stress reduction; Unstructured program using mobile application for stress reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Menopausal aging due to stress and inflammation of the microbiome	Measurement of association between levels of cytokines (IL-6,TNFa)in the microbiome and telomere length	12 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Publications and helpful links

Helpful Links

• Menopause study website-Gem-Life study
• Menopause study social media page

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2021
• Primary Completion (ACTUAL): June 22, 2021
• Study Completion (ACTUAL): June 22, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Physical Activity; Mindfulness; Menopause; Oxidative Stress; Aging; Diet; Telomeres; Lifestyle Changes
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 20031704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No