AnxietyNCT07504081
Maqui Mind: Functional Food for Your Health
A study testing Functional food in people with Anxiety, run by Samanta Thomas at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Functional food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 2 Jan 2026to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Faculty of Pharmacy, University of Valparaíso
Valparaíso, Valparaiso
About this study
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.
Read more
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
- Being tested
- Placebo fruit compote, Functional food
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo fruit compoteDietary 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.
Functional foodDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Functional food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 1) and end of intervention (End of week 12)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and end of intervention (End of week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start2 Jan 2026
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samanta Thomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samanta Thomas, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504081
- Sponsor's protocol ID
- Maqui Mind
- Other IDs
- DIUV-CIDI 15/2024
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maqui Mind: Functional Food for Your Health
- ClinicalTrials.gov ID
- NCT07504081
- Acronym / sponsor ID
- Maqui Mind
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samanta ThomasUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo fruit compoteA 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. |
| Functional food | Experimental | Dietary Supplement: Functional foodA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo fruit compoteA 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 | Placebo |
| Functional foodA 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. | Dietary supplement | Functional food |
Primary outcome
Change in perceived anxiety levels
Time frame: Baseline (Day 1) and end of intervention (End of week 12)
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
3 secondary outcomes
Change in chronic stress levels
Time frame: Baseline (Day 1) and end of intervention (End of week 12)
Change in inflammatory biomarkers
Time frame: Baseline (Day 1) and end of intervention (End of week 12)
Change in dietary intake of antioxidant-rich foods
Time frame: Baseline (Day 1) and end of intervention (End of week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional food in people with Anxiety, run by Samanta Thomas at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived anxiety levels (time frame: Baseline (Day 1) and end of intervention (End of week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.