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| ID | Type | Description | Link |
|---|---|---|---|
| DIUV-CIDI 15/2024 | Other Identifier | University of ValparaÃso |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, University of ValparaÃso | ValparaÃso | Valparaiso | Chile |
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.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055951 | Functional Food |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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. |
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| 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) |