OXXYNEA® GS: Study for Glycaemia Management

N/AActive Not RecruitingNCT05926947

Fytexia87 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Prediabetic State Overweight

Interventions

Verum ADIETARY_SUPPLEMENT

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

Verum BDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Micro crystalline cellulose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UCAM Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, Spain

Outcomes

Primary Outcomes

HbA1c

Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups

Time frame: 12 weeks

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

Secondary Outcomes

Body weight

Change in the body weight measurements in comparison of the 3 groups

Time frame: 12 weeks

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

Time frame: 12 weeks

Magnetic resonance imaging (MRI)

Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups

Time frame: 12 weeks

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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