Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17

Study Overview
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Brief Summary
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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

Official Title
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A Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Mitigate Insulin Resistance and Chronic Inflammation in Patients Diagnosed With Polycystic Ovary Syndrome (PCOS)

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Ginger exosomes
* Other: Aloe exosomes
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger exosomes<br> | Other: Ginger exosomes<br>* Naturally occurring plant exosomes from ginger<br>|
| Experimental: Aloe exosomes<br> | Other: Aloe exosomes<br>* Naturally occurring plant exosomes from aloe<br>|
| Experimental: Ginger and aloe exosomes<br> | Other: Ginger exosomes<br>* Naturally occurring plant exosomes from ginger<br>Other: Aloe exosomes<br>* Naturally occurring plant exosomes from aloe<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Exosome placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, twelve weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, twelve weeks | 
| Serum Testosterone | Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL | Baseline, twelve weeks | 
| Sex hormone binding globulin | Changes in sex hormone binding globulin in nmol/L | Baseline, twelve weeks | 
| Stool sample | Gut microbiota | Baseline, twelve weeks | 
| Inflammatory marker cluster of differentiation 4 (CD4) | CD4 | Baseline, twelve weeks | 
| Inflammatory marker cluster of differentiation 8 (CD8) | CD8 | Baseline, twelve weeks | 
| Inflammatory marker Foxp3 | Foxp3 | Baseline, twelve weeks | 
| Inflammatory marker cluster of differentiation 11b (CD11b) | CD11b | Baseline, twelve weeks | 
| Inflammatory marker cluster of differentiation 33 (CD33) | CD33 | Baseline, twelve weeks | 
| Inflammatory marker F4/80 | F4/80 | Baseline, twelve weeks | 
| Inflammatory marker interleukin 10 (IL-10) | IL-10 | Baseline, twelve weeks | 
| Inflammatory marker interleukin 1b (IL-1b) | IL-1b | Baseline, twelve weeks | 
| Inflammatory marker tumor necrosis factor alpha (TNF-a) | TNF-a | Baseline, twelve weeks | 
| Inflammatory marker interleukin 6 (IL-6) | IL-6 | Baseline, twelve weeks |