OXXYNEA® GS: Study for Glycaemia Management

NCT ID: NCT05926947

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetic State Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized parallel study
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum A

Group Type EXPERIMENTAL

Verum A

Intervention Type DIETARY_SUPPLEMENT

Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract

Verum B

Group Type EXPERIMENTAL

Verum B

Intervention Type DIETARY_SUPPLEMENT

Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Micro crystalline cellulose

Interventions

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Verum A

Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract

Intervention Type DIETARY_SUPPLEMENT

Verum B

Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate

Intervention Type DIETARY_SUPPLEMENT

Placebo

Micro crystalline cellulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Fasting Plasma Glucose 75 - 125 mg/dL
* HbA1c: 5.-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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fytexia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Alcaraz

Role: PRINCIPAL_INVESTIGATOR

UCAM (Universidad Catolica San Antonio de Murcia)

Locations

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UCAM Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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GLYCOXY

Identifier Type: -

Identifier Source: org_study_id

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