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ACTIVE NOT RECRUITING
NCT07504081
NA

Maqui Mind: Functional Food for Your Health

Sponsor: Samanta Thomas

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-02

Completion Date

2026-04

Last Updated

2026-03-31

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo fruit compote

A placebo fruit compote formulated to match the experimental functional food in appearance, texture, flavor, and caloric content, but without the active ingredients (maqui, prebiotic inulin, and probiotic). The product is composed of commonly consumed food ingredients and will be administered with the same frequency and duration as the intervention product. This intervention is used as a comparator to allow blinding of participants and to control for sensory and expectancy effects.

DIETARY_SUPPLEMENT

Functional food

A functional food in the form of a fruit compote containing maqui (1g) as a source of antioxidants, inulin (1,5g) as a prebiotic, and a probiotic Bacillus coagulans bio7 (1g). The product is formulated using commonly consumed food ingredients and is designed to be safely incorporated into the participants habitual diet. The functional food will be administered according to a predefined frequency and duration, identical for all participants assigned to this intervention.

Locations (1)

Faculty of Pharmacy, University of Valparaíso

Valparaíso, Región de Valparaíso, Chile