OXXYNEA® GS: Study for Glycaemia Management

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926947
• Other study ID #: GLYCOXY
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: December 10, 2025

Study information

• Verified date: September 2023
• Source: Fytexia
• Contact: Julien Cases
• Phone: +33 467219098
• Email: jcases[@]fytexia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 10, 2025
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Prediabetic State

Intervention

Dietary Supplement:
• Verum A
Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract
• Verum B
Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate
• Placebo
Micro crystalline cellulose

Locations

Country	Name	City	State
Spain	UCAM Universidad Católica San Antonio de Murcia	Guadalupe	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups	12 weeks
Primary	Post prandial glycemia	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
Primary	Post prandial insulemia	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	Body weight	Change in the body weight measurements in comparison of the 3 groups	12 weeks
Secondary	Dual-energy X-ray (DEXA)	Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups	12 weeks
Secondary	Magnetic resonance imaging (MRI)	Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups	12 weeks
Secondary	Short Form 12 (SF-12) questionnaire	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