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Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

Primary Purpose

Hyperglycemia, Postprandial

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Verum T1
Verum T2
Verum T3
Verum T4
Verum T5
Verum T6
Verum T7
Verum T8
Verum T9
Verum T10
Verum T11
Verum T12
Verum T13
Verum T14
Verum T15
Verum T16
Verum T17
Sponsored by
Fytexia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperglycemia, Postprandial

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCAM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Verum T1

Verum T2

Verum T3

Verum T4

Verum T5

Verum T6

Verum T7

Verum T8

Verum T9

Verum T10

Verum T11

Verum T12

Verum T13

Verum T14

Verum T15

Verum T16

Verum T17

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2021
Last Updated
August 9, 2022
Sponsor
Fytexia
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1. Study Identification

Unique Protocol Identification Number
NCT04914416
Brief Title
Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects
Official Title
OxxyneaGS: Single Blinded Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Postprandial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum T1
Arm Type
Placebo Comparator
Arm Title
Verum T2
Arm Type
Experimental
Arm Title
Verum T3
Arm Type
Experimental
Arm Title
Verum T4
Arm Type
Experimental
Arm Title
Verum T5
Arm Type
Experimental
Arm Title
Verum T6
Arm Type
Experimental
Arm Title
Verum T7
Arm Type
Experimental
Arm Title
Verum T8
Arm Type
Experimental
Arm Title
Verum T9
Arm Type
Experimental
Arm Title
Verum T10
Arm Type
Experimental
Arm Title
Verum T11
Arm Type
Experimental
Arm Title
Verum T12
Arm Type
Experimental
Arm Title
Verum T13
Arm Type
Experimental
Arm Title
Verum T14
Arm Type
Experimental
Arm Title
Verum T15
Arm Type
Experimental
Arm Title
Verum T16
Arm Type
Experimental
Arm Title
Verum T17
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T1
Intervention Description
Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T2
Intervention Description
Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T3
Intervention Description
Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T4
Intervention Description
Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T5
Intervention Description
Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T6
Intervention Description
Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T7
Intervention Description
Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T8
Intervention Description
Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T9
Intervention Description
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T10
Intervention Description
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T11
Intervention Description
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T12
Intervention Description
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T13
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T14
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T15
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T16
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum T17
Intervention Description
Verum T17 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Lipid profile evolution after a meal
Time Frame
8 hours
Title
Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)
Time Frame
8 hours
Title
Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Alcaraz Ramon
Organizational Affiliation
UCAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

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