Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

Hyperglycemia, Postprandial Clinical Trial

Official title:

OxxyneaGS: Single Blinded Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914416
• Other study ID #: OXXGS
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia, Postprandial

Intervention

Dietary Supplement:
• Verum T1
Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
• Verum T2
Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
• Verum T3
Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules
• Verum T4
Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
• Verum T5
Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules
• Verum T6
Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
• Verum T7
Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules
• Verum T8
Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules.
• Verum T9
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules
• Verum T10
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules
• Verum T11
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules
• Verum T12
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules
• Verum 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.
• Verum 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.
• Verum 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.
• Verum 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.
• Verum T17
Verum T17 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.

Locations

Country	Name	City	State
Spain	UCAM	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points		8 hours
Secondary	Lipid profile evolution after a meal		8 hours
Secondary	Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)		8 hours
Secondary	Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points		8 hours