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A Real-World Evidence Study Evaluating the Effects of the Human Optimization Project Protocol on Methylation Biomarkers and Health-Related Quality of Life in Women

A Real World Evidence Trial Assessing the Effects of the Human Optimization Project Protocol on Women's Methylation Biomarkers and Health-Related Quality of Life

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07548645
Enrollment
35
Registered
2026-04-23
Start date
2026-03-01
Completion date
2026-08-25
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Longevity, Women's Health

Keywords

Women's Health, Longevity, Supplement, Functional Health

Brief summary

This study looks at whether a daily dietary supplement called HOP Box can improve markers of biological aging and overall health in women. HOP Box contains 19 ingredients selected to support cellular health, metabolism, inflammation, and longevity. Thirty-five women between the ages of 35 and 60 will take the supplement twice a day for 90 days. Researchers will measure changes in biological age using an at-home blood test that analyzes DNA methylation patterns, track sleep quality, heart rate, and heart rate variability using an Oura Ring wearable device, and assess participants' self-reported quality of life using a validated health survey (PROMIS-29). There is no placebo or control group in this pilot study - all participants will receive the supplement and serve as their own comparison over time. The goal is to gather early data on whether HOP Box shows promising health effects in women, which would inform the design of a larger, more rigorous trial in the future.

Interventions

DIETARY_SUPPLEMENTHuman Optimization Project

There is only 1 intervention in this single-arm study.

Sponsors

Human Optimization Project
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Women aged 35 to 60 years, English-speaking, and residing in the United States * Must own an Oura Ring with an active membership and a minimum of 30 days of baseline data * Willingness to comply with all study procedures, assessments, lifestyle considerations, and follow-ups for the study duration * Medically stable with no significant health changes in the past three months

Exclusion criteria

* Current use of GLP-1 receptor agonists (e.g., semaglutide, liraglutide), SGLT2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin), insulin, metformin, thiazolidinediones, acarbose, alpha-glucosidase inhibitors, or any investigational drug or supplement within the past 30 days * Current use of NAD+ precursors (nicotinamide riboside, NMN, niacin, NAD+), supplements containing active ingredients already in the HOP Box formulation, high-dose vitamin B12, berberine, alpha-lipoic acid, or other glucose-lowering supplements * Confirmed diagnosis of Type 1 or Type 2 diabetes, known liver disease (hepatitis, cirrhosis, NAFLD), kidney disease (including CKD or renal impairment), active or recent cancer (within past 5 years, excluding non-melanoma skin cancers), or severe psychiatric/mood disorders (bipolar disorder, schizophrenia, or major depressive disorder requiring hospitalization or intensive psychiatric intervention) * Known allergy, hypersensitivity, or intolerance to any active or inactive ingredient in the intervention * Participation in any other clinical trial, wellness intervention, or investigational product study within the 30 days prior to enrollment * Currently pregnant, breastfeeding, or planning to become pregnant within the next 12 months

Design outcomes

Primary

MeasureTime frameDescription
TruDiagnosticBaseline to end-of-study (month 3)Biologic Age

Secondary

MeasureTime frameDescription
PROMIS-29 v2.0Baseline, Month 1, Month 2, and Month 3PROMIS-29 v2.0 Profile Measure - Global Health Summary. Total score ranges from 29 to 145 (raw sum of all items). Higher scores indicate worse overall health burden across domains of Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Participation, Pain Interference, and Pain Intensity.
Oura RingBaseline and End-of-Study (month 3)Heart Rate Variability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026