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Biofrequency-Guided Nutrition in Spanish Adults 154 Non-Invasive Dietary
Clinical Trial NCT07082413 is an interventional study for Biofrequency-Guided Nutrition and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 154 participants. Led by Universidad de Especialidades Espiritu Santo, this study is expected to complete by 1 March 2026. The latest data from ClinicalTrials.gov was last updated on 24 July 2025.
Brief 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. The present study aims to address four main objectives: (1) to analyze the utility of the biofrequency system for non-invasive functional estimate...Show More
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....Show More
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
Conditions
Biofrequency-Guided NutritionOther Study IDs
- UALBIO2025/010
NCT ID Number
Start Date (Actual)
2025-09-01
Last Update Posted
2025-07-24
Completion Date (Estimated)
2026-03
Enrollment (Estimated)
154
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Biofrequency analysis
biomarker-based nutrition
dietary habits
mediterranean diet
nutritional biomarkers
nutritional intervention
young athletes
biomarker-based nutrition
dietary habits
mediterranean diet
nutritional biomarkers
nutritional intervention
young athletes
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalStandard diet 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) dietar...Show More | Nutritional Intervention 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 int...Show More |
No InterventionUsual diet 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | On day 0 and day 90 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | On day 0 and day 90 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- No diagnosed chronic illnesses.
- Provision of written informed consent.
- Diagnosed chronic illnesses
- No provision of written informed consent.
- 🏛️Universid...
Study Responsible Party
José Francisco López Gil, Principal Investigator, Investigador principal, Universidad de Especialidades Espiritu Santo
No contact data.