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NCT Number: NCT07548645

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Longevity Women's Health

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reputable Health

Wilmington, Delaware, 19808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Optimization Project

Dietary Supplement

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

Other names: HOP Box

Primary outcomes

  1. TruDiagnostic

    Time frame: Baseline to end-of-study (month 3)

    Biologic Age

Secondary outcomes

  1. PROMIS-29 v2.0

    Time frame: Baseline, Month 1, Month 2, and Month 3

    PROMIS-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.

  2. Oura Ring

    Time frame: Baseline and End-of-Study (month 3)

    Heart Rate Variability

Sponsors and collaborators

Lead sponsor

Human Optimization Project

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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