Biofrequency-Guided Nutrition in Spanish Adults

NCT07082413 | Not Yet Recruiting

• 1 other identifier: UALBIO2025/010
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Biofrequency-Guided Nutrition

Keywords

Biofrequency analysis; biomarker-based nutrition; dietary habits; mediterranean diet; nutritional biomarkers; nutritional intervention; young athletes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Anthropometric Data

  On day 0 and day 90

• 24-Hour Movement Behaviors

  On day 0 and day 90

• Adherence to the Mediterranean diet (MedDiet)

  On day 0 and day 90

• Tobacco smoking

  On day 0 and day 90

• Alcohol consumption

  On day 0 and day 90

Other Outcomes (1)

• Sociodemographic Data

  On day 0

Study Arms (2)

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

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.

Interventions

Nutritional Intervention OTHER

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.

Standard diet

Eligibility Criteria

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

You may qualify if:

• No diagnosed chronic illnesses.
• Provision of written informed consent.

You may not qualify if:

• Diagnosed chronic illnesses
• No provision of written informed consent.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead
• Universidad de Almeria: collaborator
• Universidad de Granada: collaborator
• Universidad de Los Lagos: collaborator
• Universidad Loyola Andalucia: collaborator

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador principal

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion: December 7, 2025
• Study Completion: March 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share