Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women

After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks).

Inclusion criteria

• Biological Female which identify themselves as Women
• Aged ≥ 40 years
• Irregular menstrual cycle for at least 3 months
• Presenting typical symptoms of perimenopause with GCS score over 20
• BMI range between 18-35 kg/m2
• Healthy woman

Exclusion criteria

• Less than 40 years old
• Pregnant
• Diagnosed with diseases related to reproductive system such as PCOS or endometriosis
• Taking anti-depressant medication or sleeping pills
• Taking hormonal replacement therapy (HRT)
• Taking conventional drug treatment or dietary supplementation
• Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months,
• Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders,
• Being medicated for these conditions,
• History of allergic reactions to saffron intake,
• Decisionally challenged subjects or unable to comply to the study
• Any conditions that could contraindicates the use of saffron
• Currently smoking or ceased smoking in the past 3 months