Prediabetic StateNCT05926947
OXXYNEA® GS: Study for Glycaemia Management
A study testing Verum A and Verum B in people with Prediabetic State and Overweight, run by Fytexia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State, Overweight
- What is being tested?
- Verum A and Verum B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
UCAM Universidad Católica San Antonio de Murcia
Guadalupe, Murcia, 30107
About this study
Official title: Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
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.
- Conditions
- Prediabetic State, Overweight
- Being tested
- Verum A, Verum B, Placebo
- Medical subject headings
- Prediabetic State, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Verum A | Experimental | Not described Receives: Dietary Supplement: Verum A |
| Verum B | Experimental | Not described Receives: Dietary Supplement: Verum B |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Body weight
Change in the body weight measurements in comparison of the 3 groups
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Jul 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz, Principal investigator, UCAM (Universidad Catolica San Antonio de Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926947
- Sponsor's protocol ID
- GLYCOXY
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
- ClinicalTrials.gov ID
- NCT05926947
- Acronym / sponsor ID
- GLYCOXY
- Conditions
- Prediabetic State, Overweight
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blind randomized parallel study
| Arm | Type | Receives |
|---|---|---|
| Verum A | Experimental | Dietary Supplement: Verum A |
| Verum B | Experimental | Dietary Supplement: Verum B |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum AFormulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract | Dietary supplement | Verum A |
| Verum BFormulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate | Dietary supplement | Verum B |
| PlaceboMicro crystalline cellulose | Dietary supplement | Placebo |
Primary outcome
HbA1c
Time frame: 12 weeks
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
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.
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.
4 secondary outcomes
Body weight
Time frame: 12 weeks
Dual-energy X-ray (DEXA)
Time frame: 12 weeks
Magnetic resonance imaging (MRI)
Time frame: 12 weeks
Short Form 12 (SF-12) questionnaire
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Prediabetic State
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Alcaraz principal investigator
UCAM (Universidad Catolica San Antonio de Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum A and Verum B in people with Prediabetic State and Overweight, run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.