ClinicalTrials.gg
Not yet recruitingNCT07093242Updated Jul 30, 2025

Epigenetic Optimization Through Biofrequency Nutrition

An interventional study of Personalized Nutritional Follow-Up in Nutrition Habits, Biomarkers / Hair and Epigenetic, sponsored by Universidad de Almeria. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Biomarker-based nutrition has demonstrated superior efficacy compared to population-level approaches in improving health outcomes. Biofrequency analysis, a non-invasive technique based on the detection of electromagnetic vibrational patterns in hair follicles, offers a promising avenue for rapid functional assessment of nutritional status and epigenetic signals without reliance on blood or urine sampling. First, to evaluate the effect of a 90-day biofrequency-guided nutritional intervention on functional epigenetic status, as reflected in changes in the optimization report generated by the S-Drive system; second, to assess changes in adherence to the Mediterranean diet, anthropometric indicators, movement behaviors, and psychological well-being. Methods: In this randomized controlled trial, adults from a Sport Team from Region of Murcia (Spain) will be allocated to an experimental group receiving individualized lifestyle recommendations based on S-Drive biofrequency analysis and to a control group with no intervention. Participants in the experimental arm will apply tailored dietary guidance over 90 days. Conclusion: This study will generate foundational evidence on the utility of biofrequency technology for precision nutrition. If positive, the findings may inform scalable, low-risk strategies for personalized dietary interventions in preventive and community health settings.

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Conditions studied

  • Nutrition Habits
  • Biomarkers / Hair
  • Epigenetic

Keywords

  • Biofrequency analysis
  • young athletes
  • nutritional intervention
  • nutritional biomarkers
  • mediterranean diet
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In context

Lead sponsor

Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 65 years.
  • Active member of a registered athletics club.
  • Willingness to provide a hair sample for genetic analysis.
  • Ability to understand and sign the form.
  • Commitment to complete the nutritional follow-up (for the intervention group) and to respond to pre- and post-intervention questionnaires.

Exclusion criteria

Exclusion Criteria:

  • Prior medical diagnosis of a genetic disorder affecting nutritional metabolism.
  • Current use of nutritional supplements or special diets prescribed for medical reasons.
  • Participation in another clinical or nutritional study during the intervention period.
  • Pregnancy or breastfeeding at the time of enrollment.
  • Inability to attend baseline or post-intervention assessments.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Experimental Group - Nutritional Follow-Up

    Participants in this group receive a genetic hair analysis and a personalized nutritional follow-up based on the results. The aim is to assess whether the nutritional intervention modifies relevant genetic or biochemical markers after the intervention period.

    Behavioral: Personalized Nutritional Follow-Up

  • No intervention
    Control Group - Results Only

    Participants in this group receive a genetic hair analysis and are provided with the results only, without any nutritional follow-up. This group serves as a comparison to evaluate the effect of the nutritional intervention in the experimental group.

Interventions

  • BehavioralPersonalized Nutritional Follow-Up

    Participants in the experimental arm will receive a individual nutritional follow-up based on their epigenetic hair analysis results. This includes dietary guidance, recommendations tailored to genetic markers, and periodic consultations with a nutritionist over 4 weeks and continuous availability to clarify doubts via email . The aim is to evaluate changes in genetic expression or health biomarkers after the intervention period.

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What researchers measure

Primary outcomes

  1. Change in biofrequency-derived epigenetic markers related to nutritional metabolism

    This outcome evaluates the correlation between the nutritional intervention and functional epigenetic status, assessed through the S-Drive optimization report. The measurement tool is the S-Drive system (Cell Wellbeing, Germany), a non-invasive device that analyzes resonance frequency patterns from hair follicle samples using proprietary bioinformatic algorithms. The report classifies physiological function into 12 domains related to nutritional metabolism (e.g., micronutrients, oxidative stress, circulatory function), assigning ordinal values to each: "not flagged" (0), "to be considered" (1), "advisable" (2), or "priority" (3). Two derived quantitative variables will be analyzed: (1) the number of domains classified as "priority" (unit: count, range: 0-12), and (2) the cumulative optimization score summing the ordinal ratings (unit: score, range: 0-36). These biofrequency will be used to assess within-subject changes and between group correlations from baseline to 90-day follow-up.

    Time frame: baseline and after 12-weeks post-intervention

  2. Adherence to the Mediterranean Diet measured by the 14-item PREDIMED questionnaire

    This outcome assesses adherence to the Mediterranean dietary pattern using the validated 14-item PREDIMED questionnaire (PREvención con DIeta MEDiterránea). Each item is scored as 0 (non-compliance) or 1 (compliance), for a total score ranging from 0 to 14. Higher scores indicate better adherence. The unit of measurement is the total PREDIMED score. A score ≥9 is considered high adherence. This variable will be measured at baseline and after the 90-day intervention to evaluate correlations between the individualized nutritional guidance and improvement in diet quality in the experimental group compared to the control group.

    Time frame: Baseline and after 12 weeks of intervention

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Study locations

No study locations are listed for this record.

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References and documents

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — The participants' data will be anonymized to protect confidentiality and will not be shared with other researchers

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07093242
Lead sponsor
Universidad de Almeria
Collaborators
Cell wellbeing
Responsible party
David Manzano (David Manzano Sánchez, Universidad de Almeria) — Principal investigator
First posted
Jul 30, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Jul 30, 2025

Study contacts

David Manzano Sánchez
Contact
dms700@ual.es
693353397 ext. +34
Leire Fradua Arteaga
Contact
leirefradua@gmail.com
644170100 ext. +34
David Manzano Sánchez
principal investigator · Universidad de Almeria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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