search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ginger exosomes
Aloe exosomes
Placebo
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Ginger exosomes

Aloe exosomes

Ginger and aloe exosomes

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2018
Last Updated
March 12, 2021
Sponsor
University of Louisville
search

1. Study Identification

Unique Protocol Identification Number
NCT03493984
Brief Title
Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left the university prior to study approval, no patients enrolled
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger exosomes
Arm Type
Experimental
Arm Title
Aloe exosomes
Arm Type
Experimental
Arm Title
Ginger and aloe exosomes
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Ginger exosomes
Intervention Description
Naturally occurring plant exosomes from ginger
Intervention Type
Other
Intervention Name(s)
Aloe exosomes
Intervention Description
Naturally occurring plant exosomes from aloe
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Exosome placebo tablet
Primary Outcome Measure Information:
Title
Change in glucose tolerance as measured by a glucose tolerance test
Description
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.
Secondary Outcome Measure Information:
Title
Change in serum insulin levels during a glucose tolerance test
Description
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
Title
Serum Testosterone
Description
Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
Time Frame
Baseline, twelve weeks
Title
Sex hormone binding globulin
Description
Changes in sex hormone binding globulin in nmol/L
Time Frame
Baseline, twelve weeks
Title
Stool sample
Description
Gut microbiota
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker cluster of differentiation 4 (CD4)
Description
CD4
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker cluster of differentiation 8 (CD8)
Description
CD8
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker Foxp3
Description
Foxp3
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker cluster of differentiation 11b (CD11b)
Description
CD11b
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker cluster of differentiation 33 (CD33)
Description
CD33
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker F4/80
Description
F4/80
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker interleukin 10 (IL-10)
Description
IL-10
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker interleukin 1b (IL-1b)
Description
IL-1b
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker tumor necrosis factor alpha (TNF-a)
Description
TNF-a
Time Frame
Baseline, twelve weeks
Title
Inflammatory marker interleukin 6 (IL-6)
Description
IL-6
Time Frame
Baseline, twelve weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Bohler, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs