Clinical Trial

Maqui Mind: Functional Food for Your Health

Active, Not Recruiting
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Record status
This record was last updated March 31, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
The project will aim to evaluate the impact of consuming a functional food on anxiety and inflammatory status in a university population, considering the growing scientific evidence linking diet to mental health through the gut-microbiota-brain axis. Anxiety disorders show a high prevalence among young adults and are associated with chronic low-grade inflammation and oxidative stress, which in turn are related to alterations in the intestinal microbiota. In this context, dietary components such as antioxidants, probiotics, and prebiotics have shown potential to modulate these processes, supporting the development of nutritional strategies aimed at promoting psychological well-being. Within this framework, the project will evaluate a functional food in the form of a fruit compote, formulated with maqui, a prebiotic (inulin), and a probiotic (Bacillus coagulans), designed to be safely and acceptably incorporated into the participants' habitual diet. The formulation will include commonly consumed ingredients in quantities that do not pose a health risk, seeking to ensure adequate palatability and adherence to the intervention. The research will correspond to an experimental and longitudinal study in humans. Participants will be young adult university students without chronic underlying diseases or conditions that could interfere with the study objectives. Participant selection will be conducted according to previously defined inclusion and exclusion criteria, in order to safeguard volunteer safety and ensure the validity of the data obtained. Participation will be voluntary and will take place after the signing of informed consent. The intervention will include the assessment of participants before and after consumption of the functional food, allowing for the analysis of changes associated with the nutritional intervention. The variables to be evaluated will include inflammatory parameters, perceived anxiety, dietary intake control, and anthropometric variables. Inflammatory parameters will be determined through the measurement of inflammatory cytokines in blood samples, which will be collected by trained healthcare personnel following standardized safety and bioethical protocols. Anxiety will be assessed using validated psychological scales of subjective perception, complemented by the determination of cortisol in nail samples, allowing for an objective and non-invasive approach to chronic stress status. Dietary intake control will be conducted through food frequency questionnaires focused on antioxidant-rich foods, with the aim of characterizing participants' habitual dietary patterns. In addition, standardized anthropometric assessments will be carried out to describe nutritional status and monitor potential variations associated with the consumption of the functional food. From a scientific and social perspective, this project will seek to generate evidence on the role of functional foods in modulating anxiety and inflammatory status in a university population. The integration of antioxidants, prebiotics, and probiotics into a single formulation will represent an innovative approach in the field of nutrition and mental health, with potential application in strategies aimed at promoting well-being and preventing anxiety-related alterations.
Trial Details
NCT Number NCT07504081
Lead Sponsor Samanta Thomas
Conditions Anxiety
Enrollment 30 participants
Start Date 2026-01-02
Primary Completion 2026-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-31