Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

NCT04914416 | Completed

• 1 other identifier: OXXGS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia, Postprandial

Outcome Measures

Primary Outcomes (1)

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

  8 hours

Secondary Outcomes (3)

• Lipid profile evolution after a meal

  8 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 points

  8 hours

Study Arms (17)

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

Interventions

Verum T1 DIETARY_SUPPLEMENT

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

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 T2 DIETARY_SUPPLEMENT

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

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 T3 DIETARY_SUPPLEMENT

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

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 T4 DIETARY_SUPPLEMENT

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

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 T5 DIETARY_SUPPLEMENT

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

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 T6 DIETARY_SUPPLEMENT

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

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 T7 DIETARY_SUPPLEMENT

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

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 T8 DIETARY_SUPPLEMENT

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

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 T9 DIETARY_SUPPLEMENT

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

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 T10 DIETARY_SUPPLEMENT

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

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 T11 DIETARY_SUPPLEMENT

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

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 T12 DIETARY_SUPPLEMENT

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

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 T13 DIETARY_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 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 T14 DIETARY_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 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 T15 DIETARY_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 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 T16 DIETARY_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 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 T17 DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Glycemia: 100-125mg/dL
• Both sexes
• Overweight BMI range (27-32)
• Age: 20-50 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fytexia: lead

Study Sites (1)

UCAM

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pedro Alcaraz Ramon

  UCAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 4, 2021
• Study Start: June 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)