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Saffron and perceived stress: grade C

Limited evidence. Direction: No effect.

C LimitedIndustry-fundedSubjective outcome only

Educational guidance, not medical advice

Why this grade

Rubric condition met: Limited: support comes from secondary outcomes and one small acute crossover trial (n=19); B not met because trials disagree (conservative reading per citation-rules 9)

Perceived stress fell versus placebo as a secondary outcome in a 4-week trial in adults with moderate insomnia (n=165), and stress and anxiety ratings fell after a single dose in 19 young men facing a lab stressor; both were supported by Activ'Inside. A 2017 trial reported lower stress-related symptoms at 28 mg/day but not 22 mg/day. The largest trial (n=202) found no between-group differences on its secondary outcomes, and a publicly funded 6-week trial found no effect on anxiety. Pooled BAI data come from mixed, largely clinical populations with I2 of 94.8%.

How we grade evidence

Studies this grade rests on

EffectMixedNo effectSize shows participants (n)2015202020252030Meta-analysisRCTCrossover RCTMahmoudi 2026, 2026: meta-analysis, n = 1,769, result not recordedLopresti 2025, 2025: RCT, n = 202, result not recordedSchuster 2025, 2025: RCT, n = 165, result not recordedKell 2017, 2017: RCT, n = 128, result not recordedAmadieu 2025, 2025: RCT, n = 51, result not recordedPouchieu 2023, 2023: crossover RCT, n = 19, result not recorded
each study this grade rests on, by publication year and design. Solid: effect versus the comparator; half-filled: mixed; hollow: no effect; dashed: result not recorded yet. Larger marks had more participants.
Show the numbers
StudyYearDesignParticipantsResult
Kell 20172017RCT128result not recorded
Pouchieu 20232023crossover RCT19result not recorded
Schuster 20252025RCT165result not recorded
Amadieu 20252025RCT51result not recorded
Lopresti 20252025RCT202result not recorded
Mahmoudi 20262026meta-analysis1769result not recorded

Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial.

Schuster J, Mundhenke C, Nordsieck H. Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial Sleep Med X, 2025. PMID 40698027

Result not recorded
Design
Randomized, double-blind, placebo-controlled, 3-arm trial (4 weeks)
Sample
n = 165
Population
Adults reporting moderate insomnia
Funding
Financial support from Activ'Inside SAS (COI statement)

Acute Effect of a Saffron Extract (Safr'Inside(TM)) and Its Main Volatile Compound on the Stress Response in Healthy Young Men: A Randomized, Double Blind, Placebo-Controlled, Crossover Study.

Pouchieu C, Pourtau L, Brossaud J. Acute Effect of a Saffron Extract (Safr'Inside(TM)) and Its Main Volatile Compound on the Stress Response in Healthy Young Men: A Randomized, Double Blind, Placebo-Controlled, Crossover Study Nutrients, 2023. PMID 37447245

Result not recorded
Design
Randomized, double-blind, placebo-controlled crossover trial (single doses, 28-day washout)
Sample
n = 19
Population
Healthy men aged 18-25 exposed to a laboratory stress test
Funding
Activ'Inside; Bpifrance PIA3 Silver Brain Food programme

Effect of saffron extract supplementation on mood in healthy adults with subclinical symptoms of depression: a randomized, double-blind placebo-controlled study.

Amadieu C, Leyrolle Q, Farneti M. 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. PMID 41047129

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (6 weeks)
Sample
n = 51
Population
Healthy adults with subclinical depressive symptoms
Funding
French National Research Agency; Partnership for Research and Innovation in the Mediterranean Area (Crossref funders)

An Examination into the Effects of a Saffron Extract (Affron) on Mood and General Wellbeing in Adults Experiencing Low Mood: A Randomized, Double-Blind, Placebo-Controlled Trial.

Lopresti AL, Smith SJ, Marx W. An Examination into the Effects of a Saffron Extract (Affron) on Mood and General Wellbeing in Adults Experiencing Low Mood: A Randomized, Double-Blind, Placebo-Controlled Trial J Nutr, 2025. PMID 40414301

Result not recorded
Design
Randomized, double-blind, placebo-controlled, 2-arm trial (12 weeks)
Sample
n = 202
Population
Adults aged 18-70 with subclinical depressive symptoms
Funding
Study sponsor Pharmactive Biotech Products SLU (two authors are its employees, per COI statement)

affron(®) a novel saffron extract (Crocus sativus L.) improves mood in healthy adults over 4 weeks in a double-blind, parallel, randomized, placebo-controlled clinical trial.

Kell G, Rao A, Beccaria G. affron(®) a novel saffron extract (Crocus sativus L.) improves mood in healthy adults over 4 weeks in a double-blind, parallel, randomized, placebo-controlled clinical trial Complement Ther Med, 2017. PMID 28735826

Result not recorded
Design
Randomized, double-blind, placebo-controlled, 3-arm trial (4 weeks)
Sample
n = 128
Population
Adults self-reporting low mood, not diagnosed with depression
Funding
Pharmactive Biotech Products SL (maker of the affron extract) (Crossref funder)

Effect of saffron on depression, anxiety and mood disorder: a GRADE assessed systematic review and meta-analysis of 34 randomized controlled trials.

Mahmoudi R, Mohammadi-Sartang M, Servatyari K. Effect of saffron on depression, anxiety and mood disorder: a GRADE assessed systematic review and meta-analysis of 34 randomized controlled trials Nutr Neurosci, 2026. PMID 41693488

Result not recorded
Design
Systematic review and meta-analysis of 34 randomized placebo-controlled trials (at least 4 weeks; GRADE assessed)
Sample
n = 1,769
Population
Adults; trials on depression, anxiety and mood disorders
Funding
not stated in PubMed or Crossref record

Search and history

Search (): (TITLE:"saffron" OR TITLE:"crocus sativus") AND (TITLE:"stress" OR TITLE:"anxiety") AND (PUB_TYPE:"Randomized Controlled Trial")

  • Graded C (proposed): Proposed in the monograph draft
  • C to C (proposed): Updated in the monograph draft
  • C to C (approved): Editor sign-off November 13, 2026: grade matches the editor-approved final page