Pure Global

A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults - Trial NCT06413810

Access comprehensive clinical trial information for NCT06413810 through Pure Global AI's free database. This phase not specified trial is sponsored by Unilever R&D and is currently Not yet recruiting. The study focuses on Stress. Target enrollment is 49 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06413810
Not yet recruiting
other
Trial Details
ClinicalTrials.gov โ€ข NCT06413810
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults

Study Focus

Stress

Calmarell

Interventional

other

Sponsor & Location

Unilever R&D

Cork, Ireland

Timeline & Enrollment

N/A

Jun 01, 2024

Oct 01, 2024

49 participants

Primary Outcome

Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention

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

ICD-10 Classifications

Stress, not elsewhere classified
Other reactions to severe stress
Reaction to severe stress, unspecified
Undue concern and preoccupation with stressful events
State of emotional shock and stress, unspecified

Data Source

ClinicalTrials.gov

NCT06413810

Non-Device Trial