Effect of Saffron Extract Supplementation on Emotional Well-being Alterations

NCT05690126 | Unknown

• 1 other identifier: 2022-A01556-37
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Saffron extract; Depressive Symptoms; Fatigue; Emotional wellbeing; Sleep quality; Anxiety; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change 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).

  Baseline (V1) and 6 weeks (V2)

Secondary Outcomes (14)

• Change in mood

  Baseline (V1) and 6 weeks (V2)

• Change in anxiety

  Baseline (V1) and 6 weeks (V2)

• Change in stress

  Baseline (V1) and 6 weeks (V2)

• Change in fatigue

  Baseline (V1) and 6 weeks (V2)

• Change in sleep quality

  Baseline (V1) and 6 weeks (V2)

Study Arms (2)

Saffron extract

ACTIVE COMPARATOR

Daily, two dietary supplements (Saffron extract) will be taken orally with water, the first one at breakfast and the second one at dinner. Dietary supplements in capsule form

Dietary Supplement: Saffron extract

Placebo

PLACEBO COMPARATOR

Daily, two dietary supplements (Maltodextrin) will be taken orally with water, the first one at breakfast and the second at dinner. Dietary supplements in capsule form

Dietary Supplement: Maltodextrin

Interventions

Saffron extract DIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Saffron extract

Maltodextrin DIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers (as determines by medical history and clinical examination);
• Male or female between 18 and 50 years of age;
• Body Mass Index (BMI) 18.5 ≤ BMI \< 30 kg/ m2;
• Subject with subclinical symptoms of depressed mood, anxiety, fatigue and/or stress, as determined by the presence of at least 6 or more symptoms of moderate intensity among the 18 symptoms listed in the modified neurotoxicity scale (NRS).
• Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;
• Person affiliated or benefiting from a social security scheme.

You may not qualify if:

• Psychiatric comorbidity determined with the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5) or history of psychiatric illness;
• Neurodegenerative pathology (Alzheimer's disease, Parkinson's disease, dementia);
• Cardio-metabolic diseases (cardiovascular diseases, type 1 or 2 diabetes...);
• Untreated or unstabilised hypertension;
• Severe chronic diseases (cancer, severe chronic pain, HIV, hepatitis, kidney disease, autoimmune diseases, etc.);
• Chronic inflammatory diseases (Crohn's disease, coeliac disease, rheumatoid arthritis, etc.);
• Pathologies likely to act on the Hypothalamus-Pituitary-Adrenal (HPA) axis or the adrenal cortical metabolism (e.g.: Cushing syndrome);
• Untreated and/or unstabilised thyroid diseases (hypo/hyperthyroidism, Graves' disease...);
• Subjects treated during the previous 6 months or being currently treated with psychotropic drugs prescribed and/or recommended for anxiety, depression, sleep disorders and generally for any neurological or psychological type of manifestation.
• The same applies to:
• Drugs likely to have direct or indirect effects on psychiatric symptoms, notably regular use of corticoids or steroidal anti-inflammatories (e.g. Betamethasone, Cortivazol, Dexamethasone, Methylprednisolone, Prednisolone, Prednisone, Tetracosactide, Triamcinolone, etc.);
• Any drug treatment aimed at improving or maintaining cognitive functions (e.g. Aricept, Exelon, Reminyl, Ebixa etc.);
• Food supplements during the last 3 months prior to participation in this study.
• Personal or professional event with potential severe impact on the subject's emotional and/or psychological state within the last 8 weeks (e.g. but not limited to: change of job function/position, death of a family member, divorce, surgery, accident, etc.);
• Use of antibiotic treatment (\<2 months);

Sponsors & Collaborators

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

Study Sites (1)

CEN Experimental

Dijon, 21000, France

RECRUITING

Related Publications (1)

• Amadieu C, Leyrolle Q, Farneti M, Anesi A, Bruchet E, Montet J, Dexpert S, Gaudout D, Mattivi F, Pourtau L, Castanon N, Capuron L. Effect of saffron extract supplementation on mood in healthy adults with subclinical symptoms of depression: a randomized, double-blind placebo-controlled study. Am J Clin Nutr. 2025 Dec;122(6):1625-1635. doi: 10.1016/j.ajcnut.2025.09.050. Epub 2025 Oct 3.

  PMID: 41047129 DERIVED

MeSH Terms

Conditions

Depression; Fatigue; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Inflammation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes

Study Officials

• Lucile Capuron, PhD

  INRAE-Laboratory of Nutrition And Integrative Neurobiology (NutriNeuro Lab)

  STUDY DIRECTOR

Central Study Contacts

Lucile Capuron, PhD

CONTACT

+33557571233; lucile.capuron@inrae.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 19, 2023
• Study Start: December 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)