Hyperglycemia, PostprandialNCT04914416
Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects
A study testing Verum T1, Verum T2 and Verum T3 in people with Hyperglycemia, Postprandial, run by Fytexia at 1 site in Spain.
Trial summary
This study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial
- What is being tested?
- Verum T1, Verum T2 and Verum T3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Glycemia: 100-125mg/dL
- Both sexes
- Overweight BMI range (27-32)
- 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, artichoke, black currant, grapefruit, grape, white kidney bean, olive, pomegranate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OxxyneaGS: Single Blinded Randomized Study
This study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin.
- Conditions
- Hyperglycemia, Postprandial
- Being tested
- Verum T1, Verum T2, Verum T3, Verum T4, Verum T5
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum T1Dietary supplement
Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
Verum T2Dietary supplement
Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
Verum T3Dietary supplement
Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules
Verum T4Dietary supplement
Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
Verum T5Dietary supplement
Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules
Verum T6Dietary supplement
Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
Verum T7Dietary supplement
Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules
Verum T8Dietary supplement
Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules.
Verum T9Dietary supplement
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules
Verum T10Dietary supplement
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules
Verum T11Dietary supplement
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules
Verum T12Dietary supplement
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules
Verum T13Dietary supplement
Verum T13 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
Verum T14Dietary supplement
Verum T14 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 900 mg in 3 capsules.
Verum T15Dietary supplement
Verum T15 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, Zinc, and, black currant leaf extracts. Daily dosage is 1000 mg in 3 capsules.
Verum T16Dietary supplement
Verum T16 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, and Zinc. Daily dosage is 1000 mg in 3 capsules.
Verum T17Dietary supplement
Verum T17 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Verum T1 | Placebo comparator | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T2 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T3 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T4 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T5 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T6 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T7 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T8 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T9 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T10 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T11 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T12 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T13 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T14 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T15 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T16 | Experimental | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
| Verum T17 | Placebo comparator | Not described Receives: Dietary Supplement: Verum T1; Dietary Supplement: Verum T2; Dietary Supplement: Verum T3; Dietary Supplement: Verum T4; Dietary Supplement: Verum T5; Dietary Supplement: Verum T6; Dietary Supplement: Verum T7; Dietary Supplement: Verum T8; Dietary Supplement: Verum T9; Dietary Supplement: Verum T10; Dietary Supplement: Verum T11; Dietary Supplement: Verum T12; Dietary Supplement: Verum T13; Dietary Supplement: Verum T14; Dietary Supplement: Verum T15; Dietary Supplement: Verum T16; Dietary Supplement: Verum T17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points
Measured: 8 hours
Secondary outcomes (3)
Lipid profile evolution after a meal
Measured: 8 hours
Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)
Measured: 8 hours
Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Jun 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, PostprandialStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz Ramon, Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914416
- Sponsor's protocol ID
- OXXGS
- Status last verified
- Aug 2022
- First submitted
- 28 May 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OxxyneaGS: Single Blinded Randomized Study
- ClinicalTrials.gov ID
- NCT04914416
- Acronym / sponsor ID
- OXXGS
- Conditions
- Hyperglycemia, Postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 4 Jun 2021 (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.
This study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Verum T1 | Placebo comparator | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T2 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T3 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T4 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T5 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T6 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T7 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T8 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T9 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T10 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T11 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T12 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T13 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T14 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T15 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T16 | Experimental | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
| Verum T17 | Placebo comparator | Dietary Supplement: Verum T1, Dietary Supplement: Verum T2, Dietary Supplement: Verum T3, Dietary Supplement: Verum T4, Dietary Supplement: Verum T5, Dietary Supplement: Verum T6, Dietary Supplement: Verum T7, Dietary Supplement: Verum T8, Dietary Supplement: Verum T9, Dietary Supplement: Verum T10, Dietary Supplement: Verum T11, Dietary Supplement: Verum T12, Dietary Supplement: Verum T13, Dietary Supplement: Verum T14, Dietary Supplement: Verum T15, Dietary Supplement: Verum T16, Dietary Supplement: Verum T17 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Glycemia: 100-125mg/dL
- Both sexes
- Overweight BMI range (27-32)
- 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 T1Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T2Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T3Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T4Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T5Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T6Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T7Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T8Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T9Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T10Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T11Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T12Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T13Verum T13 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T14Verum T14 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 900 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T15Verum T15 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, Zinc, and, black currant leaf extracts. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T16Verum T16 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, and Zinc. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
| Verum T17Verum T17 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules. | Dietary supplement | Verum T1, Verum T10, Verum T11, Verum T12, Verum T13, Verum T14, Verum T15, Verum T16, Verum T17, Verum T2, Verum T3, Verum T4, Verum T5, Verum T6, Verum T7, Verum T8, Verum T9 |
Primary outcome
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points
Time frame: 8 hours
3 secondary outcomes
Lipid profile evolution after a meal
Time frame: 8 hours
Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)
Time frame: 8 hours
Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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 Ramon principal investigator
UCAM
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 T1, Verum T2 and Verum T3 in people with Hyperglycemia, Postprandial, 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 4 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: finished, as of the sponsor's last update on 10 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points (time frame: 8 hours). 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 10 Aug 2022.