CClinicalTrials.gg
CompletedNCT04914416Updated Aug 10, 2022

Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

An interventional study of Verum T1 and Verum T2 in Hyperglycemia, Postprandial, sponsored by Fytexia. Completed at 1 site in Spain. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Fytexia · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperglycemia, Postprandial

Browse trials for

03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 10 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Fytexia is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Glycemia: 100-125mg/dL
  • Both sexes
  • Overweight BMI range (27-32)
  • 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, artichoke, black currant, grapefruit, grape, white kidney bean, olive, pomegranate.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    Verum T1

    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

  • Experimental
    Verum T2

    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

  • Experimental
    Verum T3

    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

  • Experimental
    Verum T4

    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

  • Experimental
    Verum T5

    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

  • Experimental
    Verum T6

    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

  • Experimental
    Verum T7

    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

  • Experimental
    Verum T8

    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

  • Experimental
    Verum T9

    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

  • Experimental
    Verum T10

    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

  • Experimental
    Verum T11

    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

  • Experimental
    Verum T12

    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

  • Experimental
    Verum T13

    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

  • Experimental
    Verum T14

    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

  • Experimental
    Verum T15

    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

  • Experimental
    Verum T16

    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

  • Placebo comparator
    Verum T17

    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

Interventions

  • Dietary supplementVerum T1

    Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.

  • Dietary supplementVerum T2

    Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.

  • Dietary supplementVerum T3

    Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules

  • Dietary supplementVerum T4

    Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules

  • Dietary supplementVerum T5

    Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules

  • Dietary supplementVerum T6

    Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules

  • Dietary supplementVerum T7

    Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules

  • Dietary supplementVerum T8

    Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules.

  • Dietary supplementVerum T9

    Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules

  • Dietary supplementVerum T10

    Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules

  • Dietary supplementVerum T11

    Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules

  • Dietary supplementVerum T12

    Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules

  • Dietary supplementVerum T13

    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.

  • Dietary supplementVerum T14

    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.

  • Dietary supplementVerum T15

    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.

  • Dietary supplementVerum T16

    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.

  • Dietary supplementVerum T17

    Verum T17 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.

06

What researchers measure

Primary outcomes

  1. Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points

    Time frame: 8 hours

Secondary outcomes

  1. Lipid profile evolution after a meal

    Time frame: 8 hours

  2. Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)

    Time frame: 8 hours

  3. Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points

    Time frame: 8 hours

07

Study locations

1 site
  • UCAM
    Murcia, 30107, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04914416
Lead sponsor
Fytexia
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Jun 15, 2021
Primary completion
Apr 30, 2022
Completion
May 30, 2022
Last update
Aug 10, 2022

Study contacts

Pedro Alcaraz Ramon
principal investigator · UCAM

Oversight

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

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