Theronomic Ova-All Care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (PCOS). In this study, a total of 16 participants with PCOS diagnosed by a gynaecologist will be invited to take Ova-All Care, two capsule once a day, for 12 weeks. Biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Two capsules of Theronomic Ova-All Care, one a day, for 12 weeks. Ova-All Care is a tribiotic, a health product that includes prebiotics, probiotics, and postbiotics. Ova-All Care affects ovarian health by regulating the gut microbiome, which affects oestrogen production and other factors.
Pony Testing Centre
Suzhou, Jiangsu, China
Serum oestrogen level
Serum oestrogen levels determined by blood test, pg/mL We will conduct two subgroup analyses with participants with excessively low (less than 25 pg/mL) and excessively high (more than 138 pg/mL) serum oestrogen levels
Time frame: From enrollment to end-of intervention (Week 12)
HbA1c
Haemoglobin A1c in percentage. We will conduct a subgroup analysis with participants who have an abnormal HbA1c (more than 5.9%) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Fasting Blood Glucose
Fasting Blood Glucose (FBG), in mmol/L We will conduct a subgroup analysis with participants who have an abnormal FBG (more than 6.22 mmol/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Insulin
Serum insulin level, μU/mL. We will conduct a subgroup analysis with participants who have an abnormal insulin (more than 24.8 μU/mL) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance, no unit. We will conduct a subgroup analysis with participants who had abnormal HOMA-IR (more than 2.0) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
LH
Luteinising hormone, in IU/L. We will conduct a subgroup analysis with participants who had abnormal LH (more than 11.6) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
LH/FSH
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Ratio of luteinising hormone on follicle-stimulating hormone. We will conduct a subgroup analysis with participants who had abnormal LH/FSH (more than 2.0) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Progesterone
Progesterone level, ng/mL. We will conduct a subgroup analysis with participants who had abnormal progesterone (more than 2.1) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Testosterone
Testosterone levels, ng/mL We will conduct a subgroup analysis with participants who had abnormal testosterone (more than 0.55 ng/mL) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Weight
Weight measured by a weight scale, in kg We will conduct two subgroup analyses with participants who are overweight (more than 25 kg/m2) and obese (more than 30 kg/m2) at baseline, respectively.
Time frame: From enrollment to end-of intervention (Week 12)
BMI
Body Mass Index, calculated based on the weight and height, in kg/m2. We will conduct two subgroup analyses with participants who are overweight (more than 25 kg/m2) and obese (more than 30 kg/m2) at baseline, respectively.
Time frame: From enrollment to end-of intervention (Week 12)
Waist size
Waist size measured with a measuring scale, in cm. We will conduct a subgroup analyses with participants who had an excessive waist circumference (more than 80 cm) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Buttocks size
Buttocks size measured with a measuring scale, in cm. We will conduct a subgroup analyses with participants who had an excessive buttocks circumference (more than 93 cm) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Thigh size
Thigh size measured with a measuring scale, in cm.
Time frame: From enrollment to end-of intervention (Week 12)
SBP
Systolic blood pressure, in mmHg. We will conduct a subgroup analyses with participants who had an excessive SBP (more than 120 mmHg) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
DBP
Diastolic blood pressure, in mmHg. We will conduct a subgroup analyses with participants who had an excessive DBP (more than 90 mmHg) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Total Cholesterol
Total cholesterol, in mmol/L. We will conduct a subgroup analyses with participants who had an excessive total cholesterol (more than 5.6 mmol/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Triglycerides
Triglycerides, in mmol/L. We will conduct a subgroup analyses with participants who had excessive triglycerides (more than 2.3 mmol/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
LDL
Low density lipoprotein, in mmol/L. We will conduct a subgroup analyses with participants who had an excessive waist circumference (more than 4.11 mmol/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
HDL
High density lipoprotein, in mmol/L. We will conduct a subgroup analyses with participants who had an excessive HDL (less than 1.15 mmol/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
hsCRP
high-specificity C-reactive protein, in mg/L. We will conduct a subgroup analyses with participants who had an excessive hsCRP (more than 4 mg/L) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Rotterdam criteria on ultrasound
Yes/No, must meet at least of the of following criteria on one ovary for "Yes" 1. ≥20 follicles per ovary, measuring 2-9 mm in diameter, OR 2. Ovarian volume \>10 mL
Time frame: From enrollment to end-of intervention (Week 12)
Cyst number
Number of cysts measured by ultrasound, in numbers
Time frame: From enrollment to end-of intervention (Week 12)
Cyst size
Size of the largest cyst, measured by ultrasound, in mm
Time frame: From enrollment to end-of intervention (Week 12)
Endometrial thickness
Endometrial thickness, measured with ultrasound, in mm
Time frame: From enrollment to end-of intervention (Week 12)
Normal ultrasound
Normal/abnormal ultrasound, based on the ultrasound report, dichotomous data
Time frame: From enrollment to end-of intervention (Week 12)
Menstrual cycle length
length of the menstrual cycle, assessed with a tracking app, in days
Time frame: From enrollment to end-of intervention (Week 12)
Normal menstrual cycle
Dichotomous data Normal = 21-35 Abnormal: more than 35 days or less than 21 days
Time frame: From enrollment to end-of intervention (Week 12)
Menstruation duration
Menstruation assessed with a self-reported questionnaire, in days
Time frame: From enrollment to end-of intervention (Week 12)
Menstrual pain
Average level of menstrual pain on a scale of 0 to 10, 10 being the most severe possible pain. No unit.
Time frame: From enrollment to end-of intervention (Week 12)
Maximal menstrual pain
Maximal level of pain experienced during menstruation, assessed with a participant-reported questionnaire, on a scale of 0 to 10, 10 being the most severe possible pain. No unit.
Time frame: From enrollment to end-of intervention (Week 12)
Quantity of menstruation
Quantity of blood in the menstruation, assessed with a participant-reported questionnaire, on a Lickert scale with 5 options: too scarce, relatively scarce, normal, relatively abundant and too abundant. In points (0 to 4).
Time frame: From enrollment to end-of intervention (Week 12)
Ovulation during last cycle
Dichotomous Ovulation: A significant increase in BBT of around 0.3°C to 0.6°C observed between the follicular and luteal phases. No ovulation: no bi-phasic feature.
Time frame: From enrollment to end-of intervention (Week 12)
Left ovary volume
Left ovary volume in mL. We will conduct a subgroup analysis with participants who had an abnormal left ovary size (more than 10 mL) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Right ovary volume
Right ovary volume in mL. We will conduct a subgroup analysis with participants who had an abnormal right ovary size (more than 10 mL) at baseline.
Time frame: From enrollment to end-of intervention (Week 12)
Ovulation
Number of participants who ovulated during their last cycle
Time frame: Baseline to end-of-intervention