- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914416
Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects
August 9, 2022 updated by: Fytexia
OxxyneaGS: Single Blinded Randomized Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Murcia, Spain, 30107
- UCAM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Verum T1
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T2
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T3
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T4
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T5
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T6
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T7
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T8
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T9
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T10
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T11
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T12
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T13
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T14
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T15
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Experimental: Verum T16
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
Placebo Comparator: Verum T17
|
Verum T1 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
Verum T2 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules.
Verum T3 is a 11500AAIU/g white kidney bean extract.
Daily dosage is 565 mg in 3 capsules
Verum T4 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T5 is a 17500AAIU/g white kidney bean extract.
Daily dosage is 371 mg in 3 capsules
Verum T6 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 1000 mg in 3 capsules
Verum T4 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 512 mg in 3 capsules
Verum T8 is a 34200AAIU/g white kidney bean extract.
Daily dosage is 190 mg in 3 capsules.
Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 1000 mg in 3 capsules
Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract).
Daily dosage is 500 mg in 3 capsules
Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 900 mg in 3 capsules
Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract).
Daily dosage is 600 mg in 3 capsules
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 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 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 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 is a placebo: microcristalline cellulose.
Daily dosage is 1000 mg in 3 capsules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points
Time Frame: 8 hours
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lipid profile evolution after a meal
Time Frame: 8 hours
|
8 hours
|
Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)
Time Frame: 8 hours
|
8 hours
|
Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro Alcaraz Ramon, UCAM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
May 28, 2021
First Submitted That Met QC Criteria
June 3, 2021
First Posted (Actual)
June 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXXGS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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