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Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

OxxyneaGS: Single Blinded Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04914416
Enrollment
10
Registered
2021-06-04
Start date
2021-06-15
Completion date
2022-05-30
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Postprandial

Brief 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.

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.

Sponsors

Fytexia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points8 hours

Secondary

MeasureTime frame
Lipid profile evolution after a meal8 hours
Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)8 hours
Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points8 hours

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026