The purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Naturally occurring plant exosomes from ginger
Naturally occurring plant exosomes from aloe
Exosome placebo tablet
University of Louisville
Louisville, Kentucky, United States
Change in glucose tolerance as measured by a glucose tolerance test
A glucose challenge test will be administered after initially obtaining a fasting serum glucose(baseline), then administering a 75 gram glucose load orally, then a serum glucose will be obtained 2 hours later. Serum glucose is measured in mg/dL.
Time frame: Baseline, twelve weeks.
Change in serum insulin levels during a glucose tolerance test
Serum insulin levels in multi-international units per litre (mIU/L) will be measured at baseline and after 2 hours during a 2-hour glucose tolerance test
Time frame: Baseline, twelve weeks
Serum Testosterone
Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
Time frame: Baseline, twelve weeks
Sex hormone binding globulin
Changes in sex hormone binding globulin in nmol/L
Time frame: Baseline, twelve weeks
Stool sample
Gut microbiota
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 4 (CD4)
CD4
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 8 (CD8)
CD8
Time frame: Baseline, twelve weeks
Inflammatory marker Foxp3
Foxp3
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Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 11b (CD11b)
CD11b
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 33 (CD33)
CD33
Time frame: Baseline, twelve weeks
Inflammatory marker F4/80
F4/80
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 10 (IL-10)
IL-10
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 1b (IL-1b)
IL-1b
Time frame: Baseline, twelve weeks
Inflammatory marker tumor necrosis factor alpha (TNF-a)
TNF-a
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 6 (IL-6)
IL-6
Time frame: Baseline, twelve weeks