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Active, not recruitingNCT05926947Updated Sep 18, 2025

OXXYNEA® GS: Study for Glycaemia Management

An interventional study of Verum A and Verum B in Prediabetic State and Overweight, sponsored by Fytexia. Active, not recruiting at 1 site in Spain. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Fytexia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prediabetic State
  • Overweight
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
87 participants (estimated)

Study arms

  • Experimental
    Verum A

    Dietary Supplement: Verum A

  • Experimental
    Verum B

    Dietary Supplement: Verum B

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVerum A

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

  • Dietary supplementVerum B

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

  • Dietary supplementPlacebo

    Micro crystalline cellulose

05

What researchers measure

Primary outcomes

  1. HbA1c

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

    Time frame: 12 weeks

  2. 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

  3. 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

  1. Body weight

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

    Time frame: 12 weeks

  2. 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

  3. 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

  4. 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

06

Study locations

1 site
  • UCAM Universidad Católica San Antonio de Murcia
    Guadalupe, Murcia 30107, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05926947
Lead sponsor
Fytexia
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
Jul 5, 2023
Primary completion
Oct 30, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Sep 18, 2025

Study contacts

Pedro Alcaraz
principal investigator · UCAM (Universidad Catolica San Antonio de Murcia)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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