Active Research

Our Focus Area

MetaboLonge focuses on visceral adiposity as a measurable driver of cardiometabolic risk in postmenopausal women. The study evaluates whether a structured, physician-led menopause-focused intervention can reduce visceral fat and improve metabolic health, patient-reported outcomes, and Medicare fee-for-service cost outcomes.

STUDY AT A GLANCE

Design: 1:1 randomized controlled trial
Duration: 36 Months
Participants: 2,000 postmenopausal Original Medicare FFS women
Arms: Treatment arm vs. usual-care control arm
Primary Endpoint: Month 12

Aim

MetaboLonge aims to evaluate whether a structured Functional and Lifestyle Medicine intervention can reduce visceral adiposity and improve health outcomes in postmenopausal women enrolled in Original Medicare.

Hypothesis

Menopause-focused intervention will reduce visceral adiposity compared with usual care.
Improved visceral fat outcomes will support better cardiometabolic risk markers.
Metabolic improvements may reduce healthcare utilization and Medicare FFS costs.

Background & Scientific Rationale

After menopause, visceral fat can increase even when body weight or BMI does not clearly show the risk. This fat is linked to insulin resistance, dyslipidemia, hypertension, inflammation, cognitive risk, and higher healthcare use. MetaboLonge studies whether physician-led menopause care, six-pillar lifestyle medicine, body composition monitoring, and health coaching can reduce visceral adiposity and improve metabolic health and healthy aging outcomes.

Primary & Secondary Conditions

Primary Condition: Visceral adiposity, defined as visceral fat area ≥100 cm² confirmed by bioimpedance analysis.

Secondary Conditions / Outcomes

Insulin resistance
Prediabetes
Dyslipidemia
Hypertension
Early cognitive decline

Inclusion Criteria

Postmenopausal women
Age 65 years and older
Enrolled in Original Medicare FFS
Confirmed visceral adiposity
Visceral fat area ≥100 cm² by bioimpedance analysis

Exclusion Criteria

Advanced dementia
Active cancer treatment
Enrollment in Medicare Advantage

Randomized Study Design

MetaboLonge uses a 1:1 randomized controlled trial design.

3,200

Expected to be Screened

2,000

Participant Enrollment Target

1,000

Treatment Arm

1,000

Control Arm

Intervention Overview, Six-Pillar Framework & Visit Timeline

MetaboLonge integrates menopause-focused hormonal management with a standardized six-pillar lifestyle model and longitudinal bioimpedance measurement to address visceral adiposity and cardiometabolic risk in postmenopausal women.

Intervention
Overview

MetaboLonge combines clinically indicated menopausal hormone therapy, six-pillar lifestyle medicine, longitudinal body composition monitoring, targeted diagnostics, individualized nutrition therapy, quarterly care plan updates, laboratory monitoring, cognitive assessment, and continuous health coaching.

Six-Pillar Framework

Nutrition

Glycemic control and anti-inflammatory nutrition

Physical Activity

Resistance and aerobic activity for metabolism

Sleep

Evidence-based support for better sleep quality

Stress Management

Behavioral tools for stress and resilience

Avoidance of Risky Substances

Counseling for alcohol and tobacco reduction

Social Connection

Coaching and peer support for adherence

Intervention
Components

Longitudinal body composition assessment with visceral fat measurement
Individualized medical nutrition therapy
Six-pillar lifestyle coaching
Baseline lifestyle tracking through the MetaboLonge Health Journal
Individualized 90-day care plans updated quarterly
Quarterly laboratory monitoring
MoCA at baseline and annual reviews

Preliminary Results & Outcome Targets

Early data show promising weight and visceral fat reduction signals while longer-term outcomes continue to be evaluated.

31

Patients with Complete Weight Data

81%

Patients Showing Weight Reduction

29

Patients with Complete Visceral Fat Measurements

69%

Patients Showing Visceral Fat Reduction

Preliminary Implementation Results

Pilot Phase Results

MetaboLonge’s early implementation findings show measurable changes in weight and visceral fat outcomes among participants with complete follow-up data.

7.7 lbs

Avg. Weight Reduction

5.5%

Avg. Visceral Fat Drop

12Month

Primary Endpoint Check

Book an Appointment

Outcome Targets Graph

Outcome Targets at 12 Months

Visceral Fat Area

banner 10–15%

32%

HOMA-IR

banner 20–35%

32%

PSS-10 Score

banner 10–15%

32%

LDL Cholesterol

banner 10–15%

32%

Medicare FFS Costs

banner 08–12%

32%

STUDY PARTICIPATION

Recruitment, Enrollment & Retention

MetaboLonge is designed to recruit eligible postmenopausal Original Medicare FFS women with confirmed visceral adiposity and support long-term participation through structured follow-up, health coaching, and individualized care planning.

FOUNDED BY

Enrollment Timeline

TimepointMilestone
Month 4Program launch; first participants enrolled
Month 12Approximately 1,000–1,200 participants enrolled
Month 18 Full enrollment of 2,000 participants reached
Month 30All participants complete primary 12-month endpoint
Month 36Extended follow-up, claims analysis, and study closeout

Recruitment Strategy

MetaboLonge expects to screen approximately 3,200 postmenopausal Original Medicare FFS women to achieve the 2,000-participant enrollment target.

Referrals will be generated through Galleria Women’s Health’s physician referral network, Nevada SHIP, community health education presentations, and direct outreach through the Health Educator / Outreach and Retention Coordinator.

Retention Model

Flexible split-visit structure
Certified Health Coach support between visits
Health Educator monitoring and re-engagement
Individualized 90-day care plans updated quarterly
Objective progress tracking through body composition, labs, and lifestyle review
Annual review incentives

Data, Ethics & Research Governance

MetaboLonge uses structured data collection, IRB oversight, HIPAA-compliant processes, and CMS claims linkage to support ethical research conduct, participant safety, and reliable outcome evaluation.

Data Management

REDCap electronic data capture
Medicare Beneficiary Identifier linkage
HIPAA-compliant PHI and PII management
Clinical outcome tracking through InBody 970, laboratory panels, blood pressure, and anthropometric data
CMS Medicare claims data linkage for cost and utilization outcomes

Ethics & Oversight

WCG IRB oversight
IRB approval before enrollment
Informed consent before study procedures
HIPAA Privacy Rule compliance
45 CFR Part 46 compliance
Adverse events monitored and reported

Discussion / Conclusion

MetaboLonge is designed to evaluate whether a physician-led, menopause-focused Functional and Lifestyle Medicine intervention can reduce visceral adiposity and improve cardiometabolic health in postmenopausal Original Medicare women.

By combining clinically indicated hormone therapy, six-pillar lifestyle medicine, longitudinal body composition measurement, validated outcome tools, and CMS claims-based cost evaluation, the study aims to generate evidence for improving metabolic health, healthy aging, and Medicare fee-for-service outcomes.

MetaboLonge

Menopause, Metabolic Health & Longevity

36-Month Study

14 Structured Encounters

2,000 Participants

1:1 Randomized Design

Active Research

Our Focus Area

STUDY AT A GLANCE

Aim

Hypothesis

Background & Scientific Rationale

Primary & Secondary Conditions

Secondary Conditions / Outcomes

Inclusion Criteria

Exclusion Criteria

Randomized Study Design

3,200

2,000

1,000

1,000

Intervention Overview, Six-Pillar Framework & Visit Timeline

Intervention Overview

Six-Pillar Framework

Nutrition

Physical Activity

Sleep

Stress Management

Avoidance of Risky Substances

Social Connection

Intervention Components

Visit Timeline

Day 1

Day 15

Months 3, 6, 9, 15, 18, 21, 27, 30, 33

Months 12, 24, 36:

Month 12

Month 36

Preliminary Results & Outcome Targets

31

81%

29

69%

Preliminary Implementation Results

Pilot Phase Results

7.7 lbs

5.5%

12Month

Outcome Targets Graph

Visceral Fat Area

HOMA-IR

PSS-10 Score

LDL Cholesterol

Medicare FFS Costs

STUDY PARTICIPATION

Recruitment, Enrollment & Retention

FOUNDED BY

Enrollment Timeline

Recruitment Strategy

Retention Model

Data, Ethics & Research Governance

Data Management

Ethics & Oversight

Discussion / Conclusion

Appointment Form

Intervention
Overview

Intervention
Components