Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413810
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
A Randomised Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults
Sponsor:
Unilever RD
Organization:
Unilever RD
Study Overview
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None