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

Perimenopausal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227858
• Other study ID #: LUMHS/REC/-221
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: Dr. Amjad Khan, DPhil
• Phone: + 92 333 0506955
• Email: amjadkhan[@]lumhs.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 15, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Perimenopausal Disorder

Intervention

Dietary Supplement:
• Safr'Inside supplement (Activ'Inside, SAS)
Dietary supplementation will be taken in addition to habitual diet of the patients

Other:
• Plcebo
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)

Locations

Country	Name	City	State
Pakistan	Department of Biochemistry, LUMHS	Jamshoro	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences	Activ'inside, University of East Anglia

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on overall perimenopause clinical symptoms severity	Changes in Greene Climacteric Scale (GCS) score	6-weeks, 12-weeks
Secondary	Effect on sleep quality	Changes in Pittsburg sleep quality index (PSQI) score	6-weeks, 12-weeks
Secondary	Effect on mood	Changes in Profile of Mood State (POMS) score	6-weeks, 12-weeks
Secondary	Effect on quality of life	Changes in Short Form Health Survey (SF-36) score	6-weeks, 12-weeks
Secondary	Exploratory measures	Changes in fasting plasma glucose level	12-weeks
Secondary	Exploratory measures	Changes in gut microbiome (16S RNA Seq)	12-weeks
Secondary	Exploratory measures	Changes in FSH levels	12-weeks
Secondary	Exploratory measures	Changes in LH levels	12-weeks
Secondary	Exploratory measures	Changes in TSH levels	12-weeks