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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
50
Food supplements are taken during 6 weeks by healthy volunteers
Food supplements are taken during 6 weeks by healthy volunteers
CEN Experimental
Dijon, France
RECRUITINGChange in emotional well-being composite score
The primary endpoint is the change from baseline (V1) to 6 weeks (V2) in the composite Z-score of emotional well-being combining three components: depression (BDI score), anxiety (STAI state score) and fatigue (MFI score).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in mood
Beck Depression Inventory (score 0-39).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in anxiety
State-Trait Anxiety Inventory (score 20-80).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in stress
Visual analog scale for stress (score 0 to 10).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in fatigue
Multidimensional Fatigue Inventory (MFI) (score 20-100).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in sleep quality
The Pittsburgh Sleep Quality Index (PSQI) (score 0 to 21).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in neurovegetative symptomatology
Neurotoxic rating scale (NRS) (score 0 to 152).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in quality of life
Medical Outcome Study Short Form 12 (SF-12) (score 0 to 100).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in dietary intake
Subjects will complete a food diary in which they will register all the food and drinks consumed during 3 defined days (two weekdays and one weekend day). The Programme national nutrition santé (PNNS) questionnaire is a non-quantitative food frequency questionnaire. The 12 items are based on the recommendations of the French National Nutrition and Health.
Time frame: Baseline (V1) and 6 weeks (V2)
Change in stress response system
Salivary cortisol as a measure of the stress response system.
Time frame: Baseline (V1) and 6 weeks (V2)
Change in inflammatory markers
Blood levels of acute phase proteins and cytokines.
Time frame: Baseline (V1) and 6 weeks (V2)
Change in oxidative stress
Blood oxidative stress markers such as malondialdehyde (MDA), total antioxidant capacity (TCA) and superoxide dismutase (SOD) levels.
Time frame: Baseline (V1) and 6 weeks (V2)
Change in saffron metabolites
Blood and urine polyphenols and carotenoids levels.
Time frame: Baseline (V1) and 6 weeks (V2)
Change in metabolome
Untargeted metabolomics analysis in blood and urine samples using nuclear magnetic resonance (NMR) and/or liquid chromatography-mass spectrometry (LC-MS).
Time frame: Baseline (V1) and 6 weeks (V2)
Change in lipid profile
Lipids profile in red blood cells.
Time frame: Baseline (V1) and 6 weeks (V2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.