NCT05690126

Effect of Saffron Extract Supplementation on Emotional Well-being Alterations

Investigation of the Effect of Saffron Extract Supplementation on Emotional Well-being Alterations in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to test whether a saffron extract represents a good candidate to improve emotional well-being in subjects with subclinical symptoms of depression, fatigue, stress or anxiety. Given that mild depression, both subclinical and chronic, was shown to predispose to major clinical depression, early initiation of neuroactive nutrient supplementation may be useful to prevent or counteract the onset of chronic depression. The main objective of this study is to evaluate the efficacy of nutritional supplementation with saffron extract during 6 weeks in alleviating emotional well-being alterations in healthy adults presenting subclinical symptoms of depressed mood, anxiety, fatigue and/or stress. The secondary objectives are to assess the impact of saffron extract supplementation on the mood and neurovegetative components of emotional well-being and quality of life, namely: * depressive and anxious symptoms; * neurovegetative symptoms (fatigue, sleep quality); * perceived stress and quality of life. The exploratory objectives correspond to the biological assays for the evaluation of * the stress response system (stress hormones); * the inflammatory status; * saffron metabolites; * metabolome.

Conditions

• Mood Disturbance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Saffron extract	Food supplements are taken during 6 weeks by healthy volunteers
DIETARY_SUPPLEMENT	Maltodextrin	Food supplements are taken during 6 weeks by healthy volunteers

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-01-19
• Last updated: 2023-02-03

Locations

1 site across 1 country: France