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

April 21, 2026 updated by: Mackenzie De Jesus, Human Optimization Project

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19808
        • Reputable Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human Optimization Project Arm
This arm will receive the active supplement.
Dietary supplement: Human Optimization Project
There is only 1 intervention in this single-arm study.
Other Names:
  • HOP Box

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TruDiagnostic
Time Frame: Baseline to end-of-study (month 3)
Biologic Age
Baseline to end-of-study (month 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 1, Month 2, and Month 3
Oura Ring
Time Frame: Baseline and End-of-Study (month 3)
Heart Rate Variability
Baseline and End-of-Study (month 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Optimization Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HOPBOX1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Women's Health

Clinical Trials on Human Optimization Project

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe