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

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)

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 Overview

• Status: Withdrawn
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Ginger exosomes; Other: Aloe exosomes; Other: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Exosome placebo tablet
Experimental: Ginger exosomes	Other: Ginger exosomes; Naturally occurring plant exosomes from ginger
Experimental: Aloe exosomes	Other: Aloe exosomes; Naturally occurring plant exosomes from aloe
Experimental: Ginger and aloe exosomes	Other: Ginger exosomes; Naturally occurring plant exosomes from ginger; Other: Aloe exosomes; Naturally occurring plant exosomes from aloe

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Henry Bohler, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 17.1114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No