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Active, Not Recruiting

NCT Number: NCT05926947

OXXYNEA® GS: Study for Glycaemia Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prediabetic State Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. HbA1c

    Time frame: 12 weeks

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

  2. Post prandial glycemia

    Time frame: 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.

  3. Post prandial insulemia

    Time frame: 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.

Secondary outcomes

  1. Body weight

    Time frame: 12 weeks

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

  2. Dual-energy X-ray (DEXA)

    Time frame: 12 weeks

    Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups

  3. Magnetic resonance imaging (MRI)

    Time frame: 12 weeks

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

  4. Short Form 12 (SF-12) questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study title

Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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