Biofrequency-Guided NutritionNCT07082413
Biofrequency-Guided Nutrition in Spanish Adults
A study testing Nutritional Intervention in people with Biofrequency-Guided Nutrition, run by Universidad de Especialidades Espiritu Santo.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of a biofrequency-guided nutritional intervention in promoting a healthy diet, improving dietary behaviors, and enhancing user satisfaction among healthy Spanish adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biofrequency-Guided Nutrition
- What is being tested?
- Nutritional Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No diagnosed chronic illnesses.
- Provision of written informed consent.
Who cannot join
- Diagnosed chronic illnesses
- No provision of written informed consent.
About this study
Official title: Application of a Frequency Measurement System for Measuring Nutritional Biomarkers: Effects of a Nutritional Intervention on Satisfaction and Improvement in Quality of Life
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of a biofrequency-guided nutritional intervention in promoting a healthy diet, improving dietary behaviors, and enhancing user satisfaction among healthy Spanish adults. The present study aims to address four main objectives: (1) to analyze the utility of the biofrequency system for non-invasive functional estimates of nutritional status; (2) to evaluate the effectiveness of the associated algorithm in generating bi-omarker-informed dietary recommendations; (3) to assess user and healthcare profes-sional acceptance and satisfaction with the tool; and (4) to examine the effects of the intervention on eating habits.
Read the detailed description
Background: 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. Objective: To evaluate the feasibility, acceptability, and preliminary efficacy of a biofrequency-guided nutritional intervention in promoting a healthy diet, improving dietary behaviors, and enhancing user satisfaction among healthy Spanish adults. Methods: In this randomized controlled trial, 154 adults from the Grupo Alcaraz Sport Association (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
- Biofrequency-Guided Nutrition
- Being tested
- Nutritional Intervention
- Keywords
- Biofrequency analysis, biomarker-based nutrition, dietary habits, mediterranean diet, nutritional biomarkers, nutritional intervention, young athletes
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionOther
This study will follow a randomized controlled trial design aimed at evaluating the impact of nutritional intervention on personal satisfaction and perceived quality of life. The protocol includes two assessment points: a baseline measurement at the start of the intervention (Day 0) and a second measurement after a follow-up period (Day 90), allowing for the analysis of with-in-subject changes associated with the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard diet | Experimental | The experimental group will undergo a standardized and comprehensive nutritional intervention designed to optimize health outcomes and improve the biomarkers under study. This intervention will incorporate both practical dietary guidelines and an educational component aimed at enhancing participants' understanding of underlying health principles. Participants will receive detailed documentation, including: (1) dietary guidelines outlining the nutritional protocol, (2) a sample monthly meal plan, (3), a structured shopping list, (4) selected recipes and (5) visual meal preparation guides. To facilitate self-monitoring, a food intake log will be provided for daily dietary tracking. The intervention will include an educational program covering key health concepts relevant to the study. Through informational materials and group sessions, participants will receive instruction on topics such as stress physiology, epigenetic mechanisms, chronic disease prevention, and mindful eating pr Receives: Other: Nutritional Intervention |
| Usual diet | No intervention | The control group will maintain their habitual dietary patterns without receiving intervention materials or support. This approach will ensure that all experimental group participants receive identical guidelines, benefiting from multiple modalities of education and support, thereby establishing a robust framework for dietary modification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Epigenetic Optimization
Functional status will be assessed with the S-Drive optimization report, which analyzes resonance frequency patterns from hair follicle samples using proprietary algorithms. The report classifies each participant's physiological functioning into 12 domains grouped into four categories: (1) Micronutrient indicators (vitamins, minerals, amino acids, fatty acids, antioxidants); (2) Systemic physiological indicators (immune system, gut health, circulatory function); (3) Epigenetic and environmental stressors (EMF, ELF radiation, toxins, additives); and (4) Dietary guidance (food choices, hydration, supplementation).
Each domain is rated on four qualitative levels: "not flagged" (0), "to be considered" (1), "advisable" (2), and "priority" (3). Two derived scores will be analyzed: the total number of "priority" domains and a cumulative optimization score (0-36). These will be used to assess within-subject changes and between-group differences from baseline to follow-up.
Measured: On day 0 and day 90
Secondary outcomes (10)
Anthropometric Data
Anthropometric data, including current body weight (in kilograms) and height (in centimeters), will be self-reported by participants. These measurements will be used to compute body mass index (BMI), which is calculated by dividing weight in kilograms by the square of height in meters (kg/m²). BMI categories will be defined in accordance with World Health Organization (WHO) standards: BMI < 18.5 ("underweight"), 18.5 ≤ BMI < 24.9 ("normal weight"), 25 ≤ BMI < 29.9 ("overweight"), 30 ≤ BMI < 34.9 ("obesity class I"), 35 ≤ BMI < 39.9 ("obesity class II"), and BMI ≥ 40 ("obesity class III") (Weir \& Jan, 2023). Although self-reported measurements may be susceptible to bias, previous research indicates that self-reported BMI estimates are generally valid in adult populations (Stommel \& Schoenborn, 2009).
Measured: On day 0 and day 90
24-Hour Movement Behaviors
Physical activity across work/school, transport, and leisure will be assessed with the validated PAS-2.1S (Valles-Medina et al., 2021). The scale has nine items: six on daily activities (weekday/weekend sleep, sedentary behavior, active physical activity, leisure, commuting) and three on weekly activities. Sleep duration is self-reported; sedentary behavior covers commuting by car/public transport and screen/reading time. The weekly subscale records light (e.g., walking), moderate (e.g., gardening), and vigorous (e.g., running) activities. Activity intensity, based on METs (Ainsworth et al., 2000), includes values such as sleep (0.9), sitting work (1.5), light activity (3.0), and vigorous activity (6.0). Daily work/transport METs are multiplied by five; sleep/leisure by seven. Missing daily hours (<24) are doubled. Total METs from daily and weekly activities yield total energy expenditure.
Measured: On day 0 and day 90
Adherence to the Mediterranean diet (MedDiet)
Adherence to the Mediterranean diet (MedDiet) will be measured using the PREvención con DIeta MEDiterránea (PREDIMED) questionnaire (Martínez-González et al., 2012). Participants will report the frequency or quantity of consumption of 12 core dietary components (e.g., fruits, vegetables, olive oil, nuts) and two related dietary habits. The 14-item tool assigns binary scores (0 or 1) to each component, with total scores ≥9 indicative of high adherence to the MedDiet.
Measured: On day 0 and day 90
Tobacco smoking
Tobacco use will be assessed with two questions. First, participants will be asked: "Have you ever smoked tobacco in your lifetime?", with response options ranging from (a) never to (g) 30 times or more. Second, adolescents will be asked about current smoking frequency: (a) I do not smoke, (b) less than once a week, (c) more than once a week but not daily, and (d) every day.
Measured: On day 0 and day 90
Alcohol consumption
Alcohol consumption will be assessed with: "Have you ever consumed alcohol in your lifetime?", offering options: never, once or twice, 3-5, 6-9, 10-19, 20-29, and 30+ times. Additionally, participants will report the frequency of different alcoholic beverages, coded into days per week: never (0), almost never (0.10), monthly (0.25), weekly (1), daily (7). The mean weekly frequency will then be calculated. Based on these data, participants will be classified as non-drinkers (never consumed alcohol), regular drinkers (weekly or more), or irregular drinkers (monthly or less). Binge drinking will be measured by asking: "Have you ever consumed enough alcohol to become intoxicated?", with options: never, once, 2-3, 4-10, and more than 10 times. Excessive consumption will be defined as having become intoxicated on at least one occasion.
Measured: On day 0 and day 90
Cannabis use
Cannabis consumption will be assessed with the question: "Have you ever used cannabis in your lifetime?", using response options: (a) never, (b) once or twice, (c) 3 to 5 times, (d) 6 to 9 times, (e) 10 to 19 times, (f) 20 to 29 times, and (g) 30 times or more.
Measured: On day 0 and day 90
Depressive Symptoms
Depressive symptoms will be measured using the Spanish version of the Beck Depression Inventory-II (BDI-II) (Sanz \& Navarro, 2003). This self-administered instrument consists of 21 items, each with four response options representing increasing severity over the preceding two weeks. Item scores range from 0 to 3, yielding a total score between 0 and 63.
Measured: On day 0 and day 90
Anxiety Symptoms
Anxiety symptoms will be evaluated using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire, validated for primary care (Löwe et al., 2008). This instrument contains seven items (Spitzer et al., 2006), assessing symptoms such as nervousness, worry, restlessness, and irritability over the previous 14 days. Items are rated on a four-point Likert scale: never (0 points), several days (1 point), half of the days (2 points), and almost every day (3 points). Total scores range from 0 to 21, with thresholds as follows: no anxiety (0-4 points), mild anxiety symptoms (5-9 points), moderate anxiety symptoms (10-14 points), and severe anxiety symptoms (15-21 points).
Measured: On day 0 and day 90
Perceived stress
Perceived stress will be assessed using the Spanish version of the Perceived Stress Scale-14 (PSS-14) (Remor, 2006; Remor \& Carrobles, 2001). This 14-item instrument utilizes a five-point response scale: never (0 points), almost never (1 point), once in a while (2 points), often (3 points), and very often (4 points). The total score is calculated by reversing the responses for items 4, 5, 6, 7, 9, 10, and 13 using the conversion scale (0=4, 1=3, 2=2, 3=1, 4=0) and then summing the scores of all 14 items. Higher scores reflect greater perceived stress.
Measured: On day 0 and day 90
Disordered eating
Disordered eating behaviors will be evaluated using the Sick, Control, One, Fat, Food (SCOFF) questionnaire, a concise and validated screening instrument designed to identify individuals at risk for eating disorders (Garcia-Campayo et al., 2005). The SCOFF consists of five items that capture core dimensions of disordered eating, including restrictive intake, preoccupation with weight and shape, and compensatory behaviors. Each item requires a binary (yes/no) response, and a score of ≥2 affirmative answers indicate an increased risk for an eating disorder.
Measured: On day 0 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion7 Dec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biofrequency-Guided NutritionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Almeria, Universidad de Granada, Universidad de Los Lagos, Universidad Loyola Andalucia
- Responsible party
- Principal investigator, José Francisco López Gil, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082413
- Sponsor's protocol ID
- UALBIO2025/010
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD (Individual Participant Data) will not be shared because the study involves sensitive human data protected under the General Data Protection Regulation (GDPR). Additionally, the biological data are generated through a proprietary device and algorithm (S-Drive, Cell Wellbeing) that are subject to confidentiality agreements, which prevent the release of raw data. As this is an exploratory randomized controlled trial, there is also no current plan for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Frequency Measurement System for Measuring Nutritional Biomarkers: Effects of a Nutritional Intervention on Satisfaction and Improvement in Quality of Life
- ClinicalTrials.gov ID
- NCT07082413
- Acronym / sponsor ID
- UALBIO2025/010
- Conditions
- Biofrequency-Guided Nutrition
- Keywords
- Biofrequency analysis, biomarker-based nutrition, dietary habits, mediterranean diet, nutritional biomarkers, nutritional intervention, young athletes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Universidad de Especialidades Espiritu SantoUniversity, hospital or other
- Collaborators
- Universidad de Almeria, Universidad de Granada, Universidad de Los Lagos, Universidad Loyola Andalucia
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 7 Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 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.
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of a biofrequency-guided nutritional intervention in promoting a healthy diet, improving dietary behaviors, and enhancing user satisfaction among healthy Spanish adults. The present study aims to address four main objectives: (1) to analyze the utility of the biofrequency system for non-invasive functional estimates of nutritional status; (2) to evaluate the effectiveness of the associated algorithm in generating bi-omarker-informed dietary recommendations; (3) to assess user and healthcare profes-sional acceptance and satisfaction with the tool; and (4) to examine the effects of the intervention on eating habits.
Detailed description
Background: 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. Objective: To evaluate the feasibility, acceptability, and preliminary efficacy of a biofrequency-guided nutritional intervention in promoting a healthy diet, improving dietary behaviors, and enhancing user satisfaction among healthy Spanish adults. Methods: In this randomized controlled trial, 154 adults from the Grupo Alcaraz Sport Association (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard diet | Experimental | Other: Nutritional InterventionThe experimental group will undergo a standardized and comprehensive nutritional intervention designed to optimize health outcomes and improve the biomarkers under study. This intervention will incorporate both practical dietary guidelines and an educational component aimed at enhancing participants' understanding of underlying health principles. Participants will receive detailed documentation, including: (1) dietary guidelines outlining the nutritional protocol, (2) a sample monthly meal plan, (3), a structured shopping list, (4) selected recipes and (5) visual meal preparation guides. To facilitate self-monitoring, a food intake log will be provided for daily dietary tracking. The intervention will include an educational program covering key health concepts relevant to the study. Through informational materials and group sessions, participants will receive instruction on topics such as stress physiology, epigenetic mechanisms, chronic disease prevention, and mindful eating pr |
| Usual diet | No intervention | –The control group will maintain their habitual dietary patterns without receiving intervention materials or support. This approach will ensure that all experimental group participants receive identical guidelines, benefiting from multiple modalities of education and support, thereby establishing a robust framework for dietary modification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No diagnosed chronic illnesses.
- Provision of written informed consent.
Key exclusion criteria (2 listed)
- Diagnosed chronic illnesses
- No provision of written informed consent.
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 |
|---|---|---|
| Nutritional InterventionThis study will follow a randomized controlled trial design aimed at evaluating the impact of nutritional intervention on personal satisfaction and perceived quality of life. The protocol includes two assessment points: a baseline measurement at the start of the intervention (Day 0) and a second measurement after a follow-up period (Day 90), allowing for the analysis of with-in-subject changes associated with the intervention. | Other | Standard diet |
Primary outcome
Functional Epigenetic Optimization
Time frame: On day 0 and day 90
Functional status will be assessed with the S-Drive optimization report, which analyzes resonance frequency patterns from hair follicle samples using proprietary algorithms. The report classifies each participant's physiological functioning into 12 domains grouped into four categories: (1) Micronutrient indicators (vitamins, minerals, amino acids, fatty acids, antioxidants); (2) Systemic physiological indicators (immune system, gut health, circulatory function); (3) Epigenetic and environmental stressors (EMF, ELF radiation, toxins, additives); and (4) Dietary guidance (food choices, hydration, supplementation). Each domain is rated on four qualitative levels: "not flagged" (0), "to be considered" (1), "advisable" (2), and "priority" (3). Two derived scores will be analyzed: the total number of "priority" domains and a cumulative optimization score (0-36). These will be used to assess within-subject changes and between-group differences from baseline to follow-up.
10 secondary outcomes
Anthropometric Data
Time frame: On day 0 and day 90
24-Hour Movement Behaviors
Time frame: On day 0 and day 90
Adherence to the Mediterranean diet (MedDiet)
Time frame: On day 0 and day 90
Tobacco smoking
Time frame: On day 0 and day 90
Alcohol consumption
Time frame: On day 0 and day 90
Cannabis use
Time frame: On day 0 and day 90
Depressive Symptoms
Time frame: On day 0 and day 90
Anxiety Symptoms
Time frame: On day 0 and day 90
Perceived stress
Time frame: On day 0 and day 90
Disordered eating
Time frame: On day 0 and day 90
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 24 Jul 2025.
- Individual participant dataSharing planned: No. IPD (Individual Participant Data) will not be shared because the study involves sensitive human data protected under the General Data Protection Regulation (GDPR). Additionally, the biological data are generated through a proprietary device and algorithm (S-Drive, Cell Wellbeing) that are subject to confidentiality agreements, which prevent the release of raw data. As this is an exploratory randomized controlled trial, there is also no current plan for public data sharing.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Biofrequency-Guided Nutrition, run by Universidad de Especialidades Espiritu Santo.
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 2 inclusion and 2 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 24 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?
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?
Functional Epigenetic Optimization (time frame: On day 0 and day 90). 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 24 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.