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

• ClinicalTrials.gov Identifier: NCT03493984
• Recruitment Status: Withdrawn
• First Posted: April 11, 2018
• Last Update Posted: March 16, 2021
• Sponsor: University of Louisville
• Information provided by (Responsible Party): University of Louisville

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

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Other: Ginger exosomes; Other: Aloe exosomes; Other: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Estimated Study Start Date: October 2019
• Estimated Primary Completion Date: May 2020
• Estimated Study Completion Date: May 2020

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: Placebo	Other: Placebo; Exosome placebo tablet

Outcome Measures

Primary Outcome Measures :

1. Change in glucose tolerance as measured by a glucose tolerance test [ Time Frame: 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 Outcome Measures :

1. Change in serum insulin levels during a glucose tolerance test [ Time Frame: 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
2. Serum Testosterone [ Time Frame: Baseline, twelve weeks ]
   Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
3. Sex hormone binding globulin [ Time Frame: Baseline, twelve weeks ]
   Changes in sex hormone binding globulin in nmol/L
4. Stool sample [ Time Frame: Baseline, twelve weeks ]
   Gut microbiota
5. Inflammatory marker cluster of differentiation 4 (CD4) [ Time Frame: Baseline, twelve weeks ]
   CD4
6. Inflammatory marker cluster of differentiation 8 (CD8) [ Time Frame: Baseline, twelve weeks ]
   CD8
7. Inflammatory marker Foxp3 [ Time Frame: Baseline, twelve weeks ]
   Foxp3
8. Inflammatory marker cluster of differentiation 11b (CD11b) [ Time Frame: Baseline, twelve weeks ]
   CD11b
9. Inflammatory marker cluster of differentiation 33 (CD33) [ Time Frame: Baseline, twelve weeks ]
   CD33
10. Inflammatory marker F4/80 [ Time Frame: Baseline, twelve weeks ]
    F4/80
11. Inflammatory marker interleukin 10 (IL-10) [ Time Frame: Baseline, twelve weeks ]
    IL-10
12. Inflammatory marker interleukin 1b (IL-1b) [ Time Frame: Baseline, twelve weeks ]
    IL-1b
13. Inflammatory marker tumor necrosis factor alpha (TNF-a) [ Time Frame: Baseline, twelve weeks ]
    TNF-a
14. Inflammatory marker interleukin 6 (IL-6) [ Time Frame: Baseline, twelve weeks ]
    IL-6

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Investigators

• Principal Investigator: Henry Bohler, MD; University of Louisville

More Information

• Responsible Party: University of Louisville
• ClinicalTrials.gov Identifier: NCT03493984
• Other Study ID Numbers: 17.1114
• First Posted: April 11, 2018
• Last Update Posted: March 16, 2021
• Last Verified: March 2021

• 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

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases