OXXYNEA® GS: Study for Glycaemia Management

Fytexia

Status: Enrolling

Conditions: Overweight; Prediabetic State

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Verum A; Dietary Supplement: Verum B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05926947

GLYCOXY

Details and patient eligibility

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.

Enrollment: 87 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 3 patient groups, including a placebo group

Verum A

Experimental group

Treatment:

Dietary Supplement: Verum A

Verum B

Experimental group

Treatment:

Dietary Supplement: Verum B

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo