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

Stress Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

A double-blind, randomised, placebo-controlled, crossover study with 6 visits over 13-weeks. Participants will consume study product or placebo for two 4-week intervention periods.

Primary Objective: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on stress.

Secondary Objectives: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on:

• Mood

• Plasma GABA levels

• Salivary cortisol awakening response (CAR)

• Acute effects on stress

• Faecal GABA ;

Related Conditions & MeSH terms

• Stress

• NCT number: NCT06413810
• Study type: Interventional
• Source: Unilever R&D
• Contact: Amelia C Jarman, PhD
• Phone: +447776490919
• Email: amelia.jarman@unilever.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Completion date: October 2024