Back to resultsOXXYNEA® GS: Study for Glycaemia Management
Primary Purpose
Prediabetic State, Overweight
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Verum A
Verum B
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetic State
Eligibility Criteria
Inclusion Criteria: Fasting Plasma Glucose 100 - 125 mg/dL HbA1c: 5.7-6.5 % Both sexes Overweight BMI range (25-30 Kg/m2) 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, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.
Sites / Locations
- UCAM Universidad Católica San Antonio de MurciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Verum A
Verum B
Placebo
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
Post prandial glycemia
Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
Post prandial insulemia
Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
Secondary Outcome Measures
Body weight
Change in the body weight measurements in comparison of the 3 groups
Dual-energy X-ray (DEXA)
Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups
Magnetic resonance imaging (MRI)
Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups
Short Form 12 (SF-12) questionnaire
Evaluation of changes in responses to SF-12 questionnaire. SF-12 questionnaire is a health related questionnaire with 12 questions. The total score range from 0-100, with higher score indicating better health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05926947
Brief Title
OXXYNEA® GS: Study for Glycaemia Management
Official Title
Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
June 10, 2025 (Anticipated)
Study Completion Date
December 10, 2025 (Anticipated)
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
The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized parallel study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum A
Arm Type
Experimental
Arm Title
Verum B
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum A
Intervention Description
Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum B
Intervention Description
Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Micro crystalline cellulose
Primary Outcome Measure Information:
Title
HbA1c
Description
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
Time Frame
12 weeks
Title
Post prandial glycemia
Description
Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
Time Frame
12 weeks
Title
Post prandial insulemia
Description
Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
Change in the body weight measurements in comparison of the 3 groups
Time Frame
12 weeks
Title
Dual-energy X-ray (DEXA)
Description
Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups
Time Frame
12 weeks
Title
Magnetic resonance imaging (MRI)
Description
Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups
Time Frame
12 weeks
Title
Short Form 12 (SF-12) questionnaire
Description
Evaluation of changes in responses to SF-12 questionnaire. SF-12 questionnaire is a health related questionnaire with 12 questions. The total score range from 0-100, with higher score indicating better health status.
Time Frame
12 weeks
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:
Fasting Plasma Glucose 100 - 125 mg/dL
HbA1c: 5.7-6.5 %
Both sexes
Overweight BMI range (25-30 Kg/m2)
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, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Cases
Phone
+33 467219098
Email
jcases@fytexia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Alcaraz
Organizational Affiliation
UCAM (Universidad Catolica San Antonio de Murcia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM Universidad Católica San Antonio de Murcia
City
Guadalupe
State/Province
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda H Chung, PhD
First Name & Middle Initial & Last Name & Degree
Linda H Chung, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
OXXYNEA® GS: Study for Glycaemia Management
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