LongevityNCT07548645
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 study testing Human Optimization Project in people with Longevity and Women's Health, run by Human Optimization Project at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Longevity, Women's Health
- What is being tested?
- Human Optimization Project
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Longevity, Women's Health
- Being tested
- Human Optimization Project
- Keywords
- Women's Health, Longevity, Supplement, Functional Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Optimization ProjectDietary supplement
Also called HOP Box
There is only 1 intervention in this single-arm study.
| Study group | Role | What they receive |
|---|---|---|
| Human Optimization Project Arm | Experimental | This arm will receive the active supplement. Receives: Dietary Supplement: Human Optimization Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
TruDiagnostic
Biologic Age
Measured: Baseline to end-of-study (month 3)
Secondary outcomes (2)
PROMIS-29 v2.0
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.
Measured: Baseline, Month 1, Month 2, and Month 3
Oura Ring
Heart Rate Variability
Measured: Baseline and End-of-Study (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Mar 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LongevityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Optimization Project
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mackenzie De Jesus, Human Optimization Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548645
- Sponsor's protocol ID
- HOPBOX1
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07548645
- Acronym / sponsor ID
- HOPBOX1
- Conditions
- Longevity, Women's Health
- Keywords
- Women's Health, Longevity, Supplement, Functional Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Human Optimization ProjectIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Optimization Project Arm | Experimental | Dietary Supplement: Human Optimization ProjectThis arm will receive the active supplement. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Optimization ProjectAlso: HOP BoxThere is only 1 intervention in this single-arm study. | Dietary supplement | Human Optimization Project Arm |
Primary outcome
TruDiagnostic
Time frame: Baseline to end-of-study (month 3)
Biologic Age
2 secondary outcomes
PROMIS-29 v2.0
Time frame: Baseline, Month 1, Month 2, and Month 3
Oura Ring
Time frame: Baseline and End-of-Study (month 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Human Optimization ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Optimization Project in people with Longevity and Women's Health, run by Human Optimization Project at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TruDiagnostic (time frame: Baseline to end-of-study (month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.