About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No diagnosed chronic illnesses.
Provision of written informed consent.
Disqualifiers
Diagnosed chronic illnesses
No provision of written informed consent.
Trial design
Parallel
Treatments tested in this trial
Nutritional Intervention
Other 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
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.
Other outcomes
Sociodemographic Data
Participants will provide self-reported information regarding their sex and age. Data will also be gathered on their current engagement in educational pursuits, employment status, participation in remunerated activities, and their specific occupation. Additionally, participants will be asked to indicate the primary reason for their most recent visit to primary care services. Educational attainment will be categorized as follows: (a) incomplete primary education (\<6 years), (b) completed primary education (6 years), (c) incomplete secondary education (\<4 years), (d) completed secondary education (4 years), (e) incomplete higher education (\<2 years of baccalaureate studies), and (f) completed higher education (2 years of baccalaureate studies or a bachelor's degree).
Locations
Sponsors and contacts
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Universidad de Especialidades Espiritu Santo
Lead sponsor
Universidad de Almeria
Collaborator
Universidad de Granada
Collaborator
Universidad de Los Lagos
Collaborator
Universidad Loyola Andalucia
Collaborator
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