Clinical trial

OXXYNEA® GS: Study for Glycaemia Management

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05926947

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 50 Years

SexAll

Healthy volunteersAccepted

ConditionPrediabetic State, Overweight

Full registry criteria

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.

Treatments and study arms

Verum A

Dietary Supplement

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

Verum B

Dietary Supplement

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

Placebo

Dietary Supplement

Micro crystalline cellulose

Primary outcomes

HbA1c12 weeks

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

Post prandial glycemia12 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 insulemia12 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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