Epigenetic Optimization Through Biofrequency Nutrition

NCT07093242 | Not Yet Recruiting

• 1 other identifier: UALBIO2025/010
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nutrition Habits; Biomarkers / Hair; Epigenetic

Keywords

Biofrequency analysis; young athletes; nutritional intervention; nutritional biomarkers; mediterranean diet

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and after 12-weeks post-intervention

• 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.

  Baseline and after 12 weeks of intervention

Study Arms (2)

Experimental Group - Nutritional Follow-Up

EXPERIMENTAL

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

Control Group - Results Only

NO INTERVENTION

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

Personalized Nutritional Follow-Up BEHAVIORAL

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.

Experimental Group - Nutritional Follow-Up

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 informed consent form.
• Commitment to complete the nutritional follow-up (for the intervention group) and to respond to pre- and post-intervention questionnaires.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Cell wellbeing: collaborator

Related Links

• Related Info

Study Officials

• David Manzano Sánchez

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Manzano Sánchez

CONTACT

693353397; dms700@ual.es

Leire Fradua Arteaga

CONTACT

644170100; leirefradua@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Manzano Sánchez

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 30, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07