Maqui Mind: Functional Food for Your Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety
• Intervention / Treatment: Dietary supplement: Placebo fruit compote; Dietary supplement: Functional food

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Región de Valparaíso
    • Valparaíso, Región de Valparaíso, Chile
      • Faculty of Pharmacy, University of Valparaíso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• University students from the Valparaíso Region, Chile.
• Young adults aged between 18 and 40 years
• General health status compatible with participation in the study.
• Ability to understand and voluntarily sign the informed consent form.
• Willingness to comply with the assigned food consumption and all study-related evaluations.

Exclusion Criteria:

• Presence of chronic diseases (oncological, renal, inflammatory gastrointestinal, or other conditions that may restrict consumption of the study food).
• Diagnosis of major psychiatric disorders that may interfere with anxiety perception (e.g., major depression, bipolar disorder, psychosis).
• Diagnosis of neurodevelopmental disorders or eating disorders.
• Use of antioxidant, prebiotic, or probiotic supplements within three months prior to study initiation.
• Use of antibiotics within three months prior to the intervention.
• Known intolerance or allergy to any of the ingredients of the functional food or placebo.
• History of gastrointestinal surgery.
• Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A placebo fruit compote formulated to match the functional food in appearance, texture, flavor, and caloric content, but without the active ingredients (maqui, inulin, and probiotic). To ensure visual similarity, the product includes food-grade coloring. It is composed of commonly consumed food ingredients and is administered following the same frequency and duration as the intervention arm.	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.
Experimental: Functional food; A fruit compote containing maqui, prebiotic inulin, and a probiotic, formulated as a single combined functional food. The product is designed to deliver antioxidant and prebiotic/probiotic components within the same matrix and is administered as one unit. Participants consume the product according to a predefined frequency and duration.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived anxiety levels	Changes in perceived anxiety levels will be evaluated before and after the intervention using validated self-report psychological questionnaires: the Depression Anxiety Stress Scales-21 items (DASS-21; total and subscale scores ranging from 0 to 42, where higher scores indicate greater symptom severity), the Generalized Anxiety Disorder 7-item scale (GAD-7; scores ranging from 0 to 21, where higher scores indicate greater anxiety severity), the Patient Health Questionnaire-9 (PHQ-9; scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity), Section 3 of the Maudsley Addiction Profile-Self Report (MAP-SR; scores vary depending on the items assessed, where higher scores indicate greater problem severity), and the State-Trait Anxiety Inventory (STAI; scores ranging from 20 to 80 for each subscale, where higher scores indicate greater anxiety). The outcome aims to assess the effect of consuming a functional food containing maqui, inulin, and a probioti	Baseline (Day 1) and end of intervention (End of week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in chronic stress levels	Chronic stress levels will be evaluated by measuring cortisol concentrations in fingernail samples collected before and after the intervention. This non-invasive biomarker will complement subjective measures of anxiety and provide an objective indicator of long-term stress exposure.	Baseline (Day 1) and end of intervention (End of week 12)
Change in inflammatory biomarkers	Changes in inflammatory status will be assessed through the measurement of circulating inflammatory cytokines in blood samples collected before and after the intervention. This outcome will allow evaluation of the effect of the functional food on systemic inflammatory parameters compared with placebo.	Baseline (Day 1) and end of intervention (End of week 12)
Change in dietary intake of antioxidant-rich foods	Dietary intake will be assessed using a food frequency questionnaire focused on the consumption of antioxidant-rich foods. The questionnaire is used to estimate the frequency and amount of intake of selected foods and does not generate a standardized total score with defined minimum or maximum values. Changes in dietary intake before and after the intervention will be analyzed to characterize habitual antioxidant consumption and to control for potential dietary influences on the study outcomes.	Baseline (Day 1) and end of intervention (End of week 12)

Collaborators and Investigators

• Sponsor: Samanta Thomas

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Functional Food
• Other Study ID Numbers: Maqui Mind; DIUV-CIDI 15/2024 (Other Identifier: University of Valparaíso)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The data collected in this study include sensitive health-related information, and participants did not provide consent for public data sharing. Aggregate and anonymized results will be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No