Mood DisturbanceSAFFROMFOODNCT05690126
Effect of Saffron Extract Supplementation on Emotional Well-being Alterations
A study testing Saffron extract and Maltodextrin in people with Mood Disturbance, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disturbance
- What is being tested?
- Saffron extract and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.);
Show all 34Show fewer
- 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);
- Recent treatment with non-steroidal anti-inflammatory drugs (<1 month);
- Bariatric surgery;
- Subject with asthma, allergies (allergic rhinitis, atopic dermatitis);
- Any documented or suspected food allergy to any component of the study products.
- Drug dependence (except tobacco);
- Tobacco use of more than 20 cigarettes per day;
- Consumption of large quantities of coffee, tea, chocolate (more than 5 cups of coffee or tea and more than 20 g of dark chocolate per day) or regular daily consumption of herbal infusions with relaxing or hypnotic properties [e.g. chamomile, valerian, passionflower etc];
- Alcohol abuse (maximum 2 drinks per day, maximum 10 drinks per week with several days of abstinence) or recreational drug use based on the participant's declaration;
- Eating disorders: anorexia and bulimia or unstable diet;
- Xerostomia or other conditions that may make saliva collection impossible;
- Subjects working shifts or in extreme conditions (e.g. cold storage);
- Intense physical activity: more than 10 hours per week of intense physical activity, or significant change in physical activity within the last 2 months, or physical activity likely to be modified within the next 6 weeks. Examples of moderate to vigorous physical activity are: carrying heavy loads, playing tennis (singles or doubles), combat sports, "fast" swimming, jogging etc. Walking is not considered a moderate intensity physical activity.
- Subjects whose language skills do not allow them to understand the questionnaires;
- Disability (psychological, visual, psychomotor, linguistic...) likely to compromise to understand and sign the consent form and to complete self-questionnaires during the study.
- Subject participating in another interventional study or being in the exclusion period of a previous clinical trial;
- Subject receiving more than 4500 euros as indemnities for participation in biomedical research within the 12 last months, including indemnities for the present study;
- Women who are pregnant, intend to become pregnant during the study or are breastfeeding.
- Hormonal state that may induce a fluctuating emotional state during the study, such as, postpartum (< 6 months after delivery) and peri-menopause (irregular menstrual cycle, hot flashes, feeling of swelling, breast tension).
- Subjects under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CEN Experimental
Dijon, 21000
Carole Perrin, MD
About this study
Official title: Investigation of the Effect of Saffron Extract Supplementation on Emotional Well-being Alterations in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study
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.
Read more
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
- Being tested
- Saffron extract, Maltodextrin
- Keywords
- Saffron extract, Depressive Symptoms, Fatigue, Emotional wellbeing, Sleep quality, Anxiety, Inflammation
- Medical subject headings
- Depression, Fatigue, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saffron extractDietary supplement
Food supplements are taken during 6 weeks by healthy volunteers
MaltodextrinDietary supplement
Food supplements are taken during 6 weeks by healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (V1) and 6 weeks (V2)
Secondary outcomes (14)
Change in mood
Beck Depression Inventory (score 0-39).
Measured: Baseline (V1) and 6 weeks (V2)
Change in anxiety
State-Trait Anxiety Inventory (score 20-80).
Measured: Baseline (V1) and 6 weeks (V2)
Change in stress
Visual analog scale for stress (score 0 to 10).
Measured: Baseline (V1) and 6 weeks (V2)
Change in fatigue
Multidimensional Fatigue Inventory (MFI) (score 20-100).
Measured: Baseline (V1) and 6 weeks (V2)
Change in sleep quality
The Pittsburgh Sleep Quality Index (PSQI) (score 0 to 21).
Measured: Baseline (V1) and 6 weeks (V2)
Change in neurovegetative symptomatology
Neurotoxic rating scale (NRS) (score 0 to 152).
Measured: Baseline (V1) and 6 weeks (V2)
Change in quality of life
Medical Outcome Study Short Form 12 (SF-12) (score 0 to 100).
Measured: 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.
Measured: Baseline (V1) and 6 weeks (V2)
Change in stress response system
Salivary cortisol as a measure of the stress response system.
Measured: Baseline (V1) and 6 weeks (V2)
Change in inflammatory markers
Blood levels of acute phase proteins and cytokines.
Measured: 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.
Measured: Baseline (V1) and 6 weeks (V2)
Change in saffron metabolites
Blood and urine polyphenols and carotenoids levels.
Measured: 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).
Measured: Baseline (V1) and 6 weeks (V2)
Change in lipid profile
Lipids profile in red blood cells.
Measured: Baseline (V1) and 6 weeks (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start8 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile Capuron, PhD, Study director, INRAE-Laboratory of Nutrition And Integrative Neurobiology (NutriNeuro Lab)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690126
- Sponsor's protocol ID
- 2022-A01556-37
- Acronym
- SAFFROMFOOD
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41047129
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Saffron Extract Supplementation on Emotional Well-being Alterations in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05690126
- Acronym / sponsor ID
- SAFFROMFOOD / 2022-A01556-37
- Conditions
- Mood Disturbance
- Keywords
- Saffron extract, Depressive Symptoms, Fatigue, Emotional wellbeing, Sleep quality, Anxiety, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saffron extract | Active comparator | Dietary Supplement: Saffron extractDaily, 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 |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinDaily, 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (34 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saffron extractFood supplements are taken during 6 weeks by healthy volunteers | Dietary supplement | Saffron extract |
| MaltodextrinFood supplements are taken during 6 weeks by healthy volunteers | Dietary supplement | Placebo |
Primary outcome
Change in emotional well-being composite score
Time frame: Baseline (V1) and 6 weeks (V2)
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).
14 secondary outcomes
Change in mood
Time frame: Baseline (V1) and 6 weeks (V2)
Change in anxiety
Time frame: Baseline (V1) and 6 weeks (V2)
Change in stress
Time frame: Baseline (V1) and 6 weeks (V2)
Change in fatigue
Time frame: Baseline (V1) and 6 weeks (V2)
Change in sleep quality
Time frame: Baseline (V1) and 6 weeks (V2)
Change in neurovegetative symptomatology
Time frame: Baseline (V1) and 6 weeks (V2)
Change in quality of life
Time frame: Baseline (V1) and 6 weeks (V2)
Change in dietary intake
Time frame: Baseline (V1) and 6 weeks (V2)
Change in stress response system
Time frame: Baseline (V1) and 6 weeks (V2)
Change in inflammatory markers
Time frame: Baseline (V1) and 6 weeks (V2)
Change in oxidative stress
Time frame: Baseline (V1) and 6 weeks (V2)
Change in saffron metabolites
Time frame: Baseline (V1) and 6 weeks (V2)
Change in metabolome
Time frame: Baseline (V1) and 6 weeks (V2)
Change in lipid profile
Time frame: Baseline (V1) and 6 weeks (V2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 41047129Amadieu 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.
- Individual participant dataSharing planned: No
Related trials for Mood Disturbance
Recruiting
Pilot Trial for Health Products on Mood and Sleep Quality
Sleep Disturbance, Emotional Disturbance
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Recruiting
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Chronic Pain, Sleep Disturbance
Recruiting
Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms
Well-Being, Psychological, Mood Disturbance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucile Capuron, PhD study director
INRAE-Laboratory of Nutrition And Integrative Neurobiology (NutriNeuro Lab)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saffron extract and Maltodextrin in people with Mood Disturbance, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucile Capuron, PhD (+33557571233, lucile.capuron@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotional well-being composite score (time frame: Baseline (V1) and 6 weeks (V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.