OXXYNEA® GS: Study for Glycaemia Management

Not Applicable

Recruiting

• Conditions: Prediabetic State; Overweight
• Interventions: Dietary Supplement: Verum A; Dietary Supplement: Verum B; Dietary Supplement: Placebo

• Registration Number: NCT05926947
• Lead Sponsor: Fytexia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-03
• Study Start: 2023-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-06-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum A	Verum A	-
Verum B	Verum B	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UCAM Universidad Católica San Antonio de Murcia; 🇪🇸 Guadalupe, Murcia, Spain