Nutrition HabitsNCT07093242
Epigenetic Optimization Through Biofrequency Nutrition
A study testing Personalized Nutritional Follow-Up in people with Nutrition Habits and Biomarkers / Hair, run by Universidad de Almeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Habits, Biomarkers / Hair, Epigenetic
- What is being tested?
- Personalized Nutritional Follow-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Functional Epigenetic Optimization Through Biofrequency-Guided Nutrition: A Randomized Controlled Trial
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
- Being tested
- Personalized Nutritional Follow-Up
- Keywords
- Biofrequency analysis, young athletes, nutritional intervention, nutritional biomarkers, mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Nutritional Follow-UpBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition HabitsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Cell wellbeing
- Responsible party
- Principal investigator, David Manzano, Universidad de Almeria
- Investigators
- David Manzano Sánchez, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093242
- Sponsor's protocol ID
- UALBIO2025/010
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The participants' data will be anonymized to protect confidentiality and will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Epigenetic Optimization Through Biofrequency-Guided Nutrition: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07093242
- Acronym / sponsor ID
- UALBIO2025/010
- Conditions
- Nutrition Habits, Biomarkers / Hair, Epigenetic
- Keywords
- Biofrequency analysis, young athletes, nutritional intervention, nutritional biomarkers, mediterranean diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Cell wellbeing
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Nutritional Follow-Up | Experimental | Behavioral: Personalized Nutritional Follow-UpParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Personalized Nutritional Follow-UpParticipants 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. | Behavioural | Experimental Group - Nutritional Follow-Up |
Primary outcome
Change in biofrequency-derived epigenetic markers related to nutritional metabolism
Time frame: baseline and after 12-weeks post-intervention
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.
Adherence to the Mediterranean Diet measured by the 14-item PREDIMED questionnaire
Time frame: Baseline and after 12 weeks of intervention
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.
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 30 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The participants' data will be anonymized to protect confidentiality and will not be shared with other researchers
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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.
David Manzano Sánchez principal investigator
Universidad de Almeria
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Nutritional Follow-Up in people with Nutrition Habits and Biomarkers / Hair, run by Universidad de Almeria.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact David Manzano Sánchez (693353397 ext. +34, dms700@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biofrequency-derived epigenetic markers related to nutritional metabolism (time frame: baseline and after 12-weeks post-intervention). The study lists 2 primary outcomes in all. 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 30 Jul 2025.