The effect of saffron supplementation on indices of oxidative stress, inflammation, mental health, and quality of life in patients with Parkinson's disease: a randomized, triple-blind, placebo-controlled clinical trial.

2026
Food & function 17(2)
- Zahra Hajhashemy
- Mohammad Bagherniya
- Omid Sadeghi
- Fariborz Khorvash
- Gholamreza Askari

PubMed: 41439298
DOI: 10.1039/d5fo01924a

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 92
Population: 92 patients with PD
Methods: Triple-blind, randomized, parallel clinical trial, 100 mg/day saffron powder or placebo for 12 weeks, intention-to-treat analysis
Blinding: Triple-blind
Duration: 12 weeks
Funding: Unclear

Rigorous Journal

Background: Regarding the antioxidant content of saffron, it could be beneficial for diseases linked to oxidative stress, such as Parkinson's disease (PD). However, there were limited human studies on the efficacy of saffron supplements on PD. Therefore, we aimed to investigate this subject. Method: The current study is a triple-blind, randomized, parallel clinical trial, which investigated the effect of 100 mg d^-1 saffron powder or placebo on 92 patients with PD for 12 weeks. The analyses were conducted based on an intention-to-treat approach. Results: The age and BMI (mean ± SE) were 68.36 ± 1.0 years and 27.09 ± 0.45 kg m^-2, respectively. Comparing the mean changes of the saffron and placebo groups confirmed significant favorable effects of saffron on C-reactive protein (CRP) values (adjusted mean difference: -3.84 mg L^-1 and 95% CI: -5.61, -2.08; P_ANCOVA < 0.001), distress (adjusted mean difference: -4.40 and 95% CI: -8.43, -0.37; P_ANCOVA = 0.03), anxiety (adjusted mean difference: -4.75 and 95% CI: -8.30, -1.20; P_ANCOVA = 0.009), depression (adjusted mean difference: -4.58 and 95% CI: -8.34, -0.81; P_ANCOVA = 0.01), cognitive status (adjusted mean difference: 0.78 and 95% CI: 0.16, 1.40; P_ANCOVA = 0.01), sleep quality (adjusted mean difference: 14.76 and 95% CI: 3.20, 26.32; P_ANCOVA = 0.01), fatigue (adjusted mean difference: -9.20 and 95% CI: -13.76, -4.65; P_ANCOVA < 0.001) and indices of quality of life including mobility (adjusted mean difference: -6.43 and 95% CI: -12.32, -0.54; P_ANCOVA = 0.03), daily activity (adjusted mean difference: -6.62 and 95% CI: -12.89, -0.34; P_ANCOVA = 0.03), cognitive impairment (adjusted mean difference: -8.07 and 95% CI: -14.39, -1.75; P_ANCOVA = 0.01), bodily discomfort (adjusted mean difference: -7.50 and 95% CI: -13.93, -1.06; P_ANCOVA = 0.02), and Parkinson's Disease Summary Index (PDSI) (adjusted mean difference: -4.86 and 95% CI: -7.48, -2.25; P_ANCOVA < 0.001). Additionally, the saffron group in comparison with the placebo group showed marginal decreases in the values of malondialdehyde (adjusted mean difference: -0.32 nmol mL^-1 and 95% CI: -0.69, 0.03; P_ANCOVA = 0.07). No side effect was observed in the groups. Conclusion: The current analysis confirmed the efficacy of 100 mg d^-1 saffron supplementation in patients with PD for 12 weeks. So, saffron supplementation could be a beneficial adjuvant therapy in the management of PD.

Research Insights

Saffron→Improved Cognitive Status
cognitive status (adjusted mean difference: 0.78 and 95% CI: 0.16, 1.40; P_ANCOVA = 0.01)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Improved Daily Activity Level
daily activity (adjusted mean difference: -6.62 and 95% CI: -12.89, -0.34; P_ANCOVA = 0.03)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Improved Mobility
mobility (adjusted mean difference: -6.43 and 95% CI: -12.32, -0.54; P_ANCOVA = 0.03)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Improved Parkinson's Disease Summary Index
Parkinson's Disease Summary Index (PDSI) (adjusted mean difference: -4.86 and 95% CI: -7.48, -2.25; P_ANCOVA < 0.001)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Improved Sleep Quality
sleep quality (adjusted mean difference: 14.76 and 95% CI: 3.20, 26.32; P_ANCOVA = 0.01)
Effect
Beneficial
Effect size
Large
Dose
100 mg/day
Saffron→Reduced Anxiety
anxiety (adjusted mean difference: -4.75 and 95% CI: -8.30, -1.20; P_ANCOVA = 0.009)
Effect
Beneficial
Effect size
Moderate
Dose
100 mg/day
Saffron→Reduced Bodily Discomfort
bodily discomfort (adjusted mean difference: -7.50 and 95% CI: -13.93, -1.06; P_ANCOVA = 0.02)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Reduced C-Reactive Protein Levels
significant favorable effects of saffron on C-reactive protein (CRP) values (adjusted mean difference: -3.84 mg L⁻¹ and 95% CI: -5.61, -2.08; P_ANCOVA < 0.001)
Effect
Beneficial
Effect size
Moderate
Dose
100 mg/day
Saffron→Reduced Cognitive Impairment
cognitive impairment (adjusted mean difference: -8.07 and 95% CI: -14.39, -1.75; P_ANCOVA = 0.01)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Saffron→Reduced Depression Symptoms
depression (adjusted mean difference: -4.58 and 95% CI: -8.34, -0.81; P_ANCOVA = 0.01)
Effect
Beneficial
Effect size
Moderate
Dose
100 mg/day
Saffron→Reduced Distress
distress (adjusted mean difference: -4.40 and 95% CI: -8.43, -0.37; P_ANCOVA = 0.03)
Effect
Beneficial
Effect size
Moderate
Dose
100 mg/day
Saffron→Reduced Fatigue
fatigue (adjusted mean difference: -9.20 and 95% CI: -13.76, -4.65; P_ANCOVA < 0.001)
Effect
Beneficial
Effect size
Moderate
Dose
100 mg/day
Saffron→Reduced Malondialdehyde
the saffron group in comparison with the placebo group showed marginal decreases in the values of malondialdehyde (adjusted mean difference: -0.32 nmol mL⁻¹ and 95% CI: -0.69, 0.03; P_ANCOVA = 0.07)
Effect
Neutral
Effect size
Small
Dose
100 mg/day

Adverse Events Reported

Saffron→Overall tolerability
No side effect was observed in the groups.
Finding
Reported