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Effect of Saffron Extract Supplementation on Emotional Well-being Alterations

NCT05690126 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    lead OTHER

Principal Investigators

  • Lucile Capuron, PhD · INRAE-Laboratory of Nutrition And Integrative Neurobiology (NutriNeuro Lab)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690126 on ClinicalTrials.gov