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

Polycystic Ovary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03493984
• Other study ID #: 17.1114
• Status: Withdrawn
• Phase: N/A
• Start date: October 2019
• Est. completion date: May 2020

Study information

• Verified date: March 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Ginger exosomes
Naturally occurring plant exosomes from ginger
• Aloe exosomes
Naturally occurring plant exosomes from aloe
• Placebo
Exosome placebo tablet

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

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