Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Effect on overall perimenopause clinical symptoms severity
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Randomisation will be processed by computer-generated random sequence number and will be performed by an independent member of the medical support team which will not be involved in the study
Eligibility Criteria
- Ages
- 40 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Saffron extract supplementation (15mg, twice daily)
The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal).
Intervention: Safr'Inside supplement (Activ'Inside, SAS) (Dietary Supplement)
Control group
The Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal).
Intervention: Plcebo (Other)
Outcomes
Primary Outcomes
Effect on overall perimenopause clinical symptoms severity
Time Frame: 6-weeks, 12-weeks
Changes in Greene Climacteric Scale (GCS) score
Secondary Outcomes
- Effect on mood(6-weeks, 12-weeks)
- Effect on sleep quality(6-weeks, 12-weeks)
- Effect on quality of life(6-weeks, 12-weeks)
- Exploratory measures(12-weeks)
Investigators
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences