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The Effects of a Food Ingredient on Self-reported Stress

NCT06413810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-01-13

No results posted yet for this study

Summary

The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product.

Participants will:

* consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between
* visit the test site 6 times over the 13 weeks
* complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples

Conditions

  • Stress

Interventions

OTHER

Calmarell

Food ingredient

OTHER

Placebo

Blinded placebo

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Timothy Dinan, Prof · Atlantia Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2024-11-22
Completion
2024-11-22

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413810 on ClinicalTrials.gov