The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
104
Dietary supplementation will be taken in addition to habitual diet of the patients
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
Department of Biochemistry, LUMHS
Jāmshoro, Sindh, Pakistan
RECRUITINGEffect on overall perimenopause clinical symptoms severity
Changes in Greene Climacteric Scale (GCS) score
Time frame: 6-weeks, 12-weeks
Effect on sleep quality
Changes in Pittsburg sleep quality index (PSQI) score
Time frame: 6-weeks, 12-weeks
Effect on mood
Changes in Profile of Mood State (POMS) score
Time frame: 6-weeks, 12-weeks
Effect on quality of life
Changes in Short Form Health Survey (SF-36) score
Time frame: 6-weeks, 12-weeks
Exploratory measures
Changes in fasting plasma glucose level
Time frame: 12-weeks
Exploratory measures
Changes in gut microbiome (16S RNA Seq)
Time frame: 12-weeks
Exploratory measures
Changes in FSH levels
Time frame: 12-weeks
Exploratory measures
Changes in LH levels
Time frame: 12-weeks
Exploratory measures
Changes in TSH levels
Time frame: 12-weeks
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