Polycystic Ovary Syndrome
Conditions
Brief summary
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
Interventions
OTHERGinger exosomes
Naturally occurring plant exosomes from ginger
OTHERAloe exosomes
Naturally occurring plant exosomes from aloe
OTHERPlacebo
Exosome placebo tablet
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-40 year * Patients must have a confirmed diagnosis of PCOS according to the Rotterdam Criteria. At least 2 of the following 3 characteristics must be present: 1. Oligo-anovulation 2. Clinical and/or biochemical signs of androgen excess and 3. Polycystic ovarian morphology (PCOM) (defined by an increased number of small antral follicles \[≥12 follicles that were \<10 mm in diameter\] or an increased individual ovarian volume \[\>10 cm3\] in 1 or both ovaries. Disorders mimicking PCOS must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors. * Of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. * Ability to understand and willingness to sign a written informed consent document. * Absence of life limiting medical conditions
Exclusion criteria
* • Pregnancy * Known HIV * Patients receiving immunosuppressive drugs * Patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels * Active malignancy in the last 5 years * Patients receiving any other investigational agent(s) * Ginger and/or aloe allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose tolerance as measured by a glucose tolerance test | Baseline, twelve weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Testosterone | Baseline, twelve weeks | Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL |
| Sex hormone binding globulin | Baseline, twelve weeks | Changes in sex hormone binding globulin in nmol/L |
| Stool sample | Baseline, twelve weeks | Gut microbiota |
| Inflammatory marker cluster of differentiation 4 (CD4) | Baseline, twelve weeks | CD4 |
| Inflammatory marker cluster of differentiation 8 (CD8) | Baseline, twelve weeks | CD8 |
| Inflammatory marker Foxp3 | Baseline, twelve weeks | Foxp3 |
| Change in serum insulin levels during a glucose tolerance test | Baseline, twelve weeks | 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 |
| Inflammatory marker cluster of differentiation 33 (CD33) | Baseline, twelve weeks | CD33 |
| Inflammatory marker F4/80 | Baseline, twelve weeks | F4/80 |
| Inflammatory marker interleukin 10 (IL-10) | Baseline, twelve weeks | IL-10 |
| Inflammatory marker interleukin 1b (IL-1b) | Baseline, twelve weeks | IL-1b |
| Inflammatory marker tumor necrosis factor alpha (TNF-a) | Baseline, twelve weeks | TNF-a |
| Inflammatory marker interleukin 6 (IL-6) | Baseline, twelve weeks | IL-6 |
| Inflammatory marker cluster of differentiation 11b (CD11b) | Baseline, twelve weeks | CD11b |
Countries
United States
Outcome results
None listed