Maqui Mind: Functional Food for Your Health

NCT07504081 | Active Not Recruiting DMC

• 2 other identifiers: Maqui MindDIUV-CIDI 15/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in chronic stress levels

  Baseline (Day 1) and end of intervention (End of week 12)

• Change in inflammatory biomarkers

  Baseline (Day 1) and end of intervention (End of week 12)

• Change in dietary intake of antioxidant-rich foods

  Baseline (Day 1) and end of intervention (End of week 12)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Functional food

EXPERIMENTAL

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

Interventions

Placebo fruit compote DIETARY_SUPPLEMENT

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.

Placebo

Functional food DIETARY_SUPPLEMENT

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.

Functional food

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samanta Thomas: lead

Study Sites (1)

Faculty of Pharmacy, University of Valparaíso

Valparaíso, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Functional Food

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 31, 2026
• Study Start: January 2, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)