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Myo-inositol, D-chiro-inositol and Glucomannan in PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03608813
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Theoreo Srl
Information provided by (Responsible Party):
Jacopo Troisi, University of Salerno

Brief Summary:
The aim of this study is to analyze the metabolic profiles in women with PCOS before and after 3 months of therapy with a combination of myo-inositol, D-chiro-inositol and glucomannan, and compare these data with a group of healthy control women.

Condition or disease Intervention/treatment
PCOS Other: Serum Metabolomics profiling

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of a Combined Treatment With Myo-inositol, D-chiro-inositol and Glucomannan in Women With PCOS
Actual Study Start Date : September 10, 2016
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Group/Cohort Intervention/treatment
Controls
Healthy subjects
Other: Serum Metabolomics profiling
Untargeted serum metabolomics profiling

Case
PCOS affected subjects
Other: Serum Metabolomics profiling
Untargeted serum metabolomics profiling




Primary Outcome Measures :
  1. Untargeted serum metabolomics profiling [ Time Frame: 6 months ]
    Identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan.


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young women with a PCOS diagnosis without intercurrent chronic illness and a matched healthy population.
Criteria

Inclusion Criteria:

  • overweight/obesity (BMI > 25 kg/m2);
  • absence of any other acute intercurrent or chronic illness;
  • a positive diagnosis of PCOS according to Rotterdam criteria.

Exclusion Criteria:

  • Use of hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608813


Sponsors and Collaborators
University of Salerno
Theoreo Srl
Investigators
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Principal Investigator: Jacopo Troisi, CEO Theoreo Srl

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacopo Troisi, Ob/Gyn Clinical Research Coordinator, University of Salerno
ClinicalTrials.gov Identifier: NCT03608813     History of Changes
Other Study ID Numbers: PCOS-01
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacopo Troisi, University of Salerno:
Metabolomics

Additional relevant MeSH terms:
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Inositol
(1-6)-alpha-glucomannan
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents