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| Name | Class |
|---|---|
| University of East Anglia | OTHER |
| Activ'inside | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saffron extract supplementation (15mg, twice daily) | Experimental | 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). |
|
| Control group | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safr'Inside supplement (Activ'Inside, SAS) | Dietary Supplement | Dietary supplementation will be taken in addition to habitual diet of the patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect on overall perimenopause clinical symptoms severity | Changes in Greene Climacteric Scale (GCS) score | 6-weeks, 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on sleep quality | Changes in Pittsburg sleep quality index (PSQI) score | 6-weeks, 12-weeks |
| Effect on mood | Changes in Profile of Mood State (POMS) score |
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Inclusion Criteria:
Exclusion Criteria:
Biologically characterised as Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biochemistry, LUMHS | Jāmshoro | Sindh | 76060 | Pakistan |
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2 x 2 factorial design
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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
| Plcebo | Other | Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) |
|
| 6-weeks, 12-weeks |
| Effect on quality of life | Changes in Short Form Health Survey (SF-36) score | 6-weeks, 12-weeks |
| Exploratory measures | Changes in fasting plasma glucose level | 12-weeks |
| Exploratory measures | Changes in gut microbiome (16S RNA Seq) | 12-weeks |
| Exploratory measures | Changes in FSH levels | 12-weeks |
| Exploratory measures | Changes in LH levels | 12-weeks |
| Exploratory measures | Changes in TSH levels | 12-weeks |