OXXYNEA® GS: Study for Glycaemia Management

September 11, 2023 updated by: Fytexia

Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants

The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Murcia
      • Guadalupe, Murcia, Spain, 30107
        • Recruiting
        • UCAM Universidad Católica San Antonio de Murcia
        • Contact:
          • Linda H Chung, PhD
        • Principal Investigator:
          • Linda H Chung, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Fasting Plasma Glucose 100 - 125 mg/dL
  • HbA1c: 5.7-6.5 %
  • Both sexes
  • Overweight BMI range (25-30 Kg/m2)
  • Age: 20-50 years old

Exclusion Criteria:

  • Metabolic/Chronical disease
  • Menopausal women
  • Being pregnant, breastfeeding or wanting to have a baby
  • Former obese with a history of yoyo effect
  • Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
  • Having started or quit smoking, having a high alcohol consumption
  • Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
  • Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Micro crystalline cellulose
Experimental: Verum A
Dietary supplement: Verum A
Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract
Experimental: Verum B
Dietary supplement: Verum B
Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 weeks
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
12 weeks
Post prandial glycemia
Time Frame: 12 weeks
Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
12 weeks
Post prandial insulemia
Time Frame: 12 weeks
Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 12 weeks
Change in the body weight measurements in comparison of the 3 groups
12 weeks
Dual-energy X-ray (DEXA)
Time Frame: 12 weeks
Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups
12 weeks
Magnetic resonance imaging (MRI)
Time Frame: 12 weeks
Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups
12 weeks
Short Form 12 (SF-12) questionnaire
Time Frame: 12 weeks
Evaluation of changes in responses to SF-12 questionnaire. SF-12 questionnaire is a health related questionnaire with 12 questions. The total score range from 0-100, with higher score indicating better health status.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fytexia

Investigators

  • Principal Investigator: Pedro Alcaraz, UCAM (Universidad Catolica San Antonio de Murcia)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLYCOXY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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