NCT06413810

The Effects of a Food Ingredient on Self-reported Stress

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Stress

Interventions

Type	Name	Description
OTHER	Calmarell	Food ingredient
OTHER	Placebo	Blinded placebo

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2024-05-14
• Last updated: 2025-01-13

Locations

1 site across 1 country: Ireland