OXXYNEA® GS: Study for Glycaemia Management

Sponsor

Fytexia (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05926947

Collaborator

(none)

Enrollment

Arms

29.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetic State Overweight	Dietary Supplement: Verum A Dietary Supplement: Verum B Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind randomized parallel studyDouble blind randomized parallel study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Jun 10, 2025

Anticipated Study Completion Date :

Dec 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo	Dietary Supplement: Placebo Micro crystalline cellulose

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo

Dietary Supplement: Placebo

Micro crystalline cellulose

Outcome Measures

Primary Outcome Measures

HbA1c [12 weeks]
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
Post prandial glycemia [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.
Post prandial insulemia [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.

Secondary Outcome Measures

Body weight [12 weeks]
Change in the body weight measurements in comparison of the 3 groups
Dual-energy X-ray (DEXA) [12 weeks]
Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups
Magnetic resonance imaging (MRI) [12 weeks]
Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups
Short Form 12 (SF-12) questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fytexia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fytexia

ClinicalTrials.gov Identifier:

NCT05926947

Other Study ID Numbers:

GLYCOXY

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Prediabetic State

Study Results

No Results Posted as of Jul 3, 2023