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Completed

NCT Number: NCT04914416

Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

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.

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Key information

Conditions

Hyperglycemia, Postprandial Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Verum T1

Dietary Supplement

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

Verum T2

Dietary Supplement

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

Verum T3

Dietary Supplement

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

Verum T4

Dietary Supplement

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

Verum T5

Dietary Supplement

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

Verum T6

Dietary Supplement

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

Verum T7

Dietary Supplement

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

Verum T8

Dietary Supplement

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

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 T10

Dietary Supplement

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

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 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 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 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 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 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 T17

Dietary Supplement

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

Primary outcomes

  1. 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 outcomes

  1. Lipid profile evolution after a meal

    Time frame: 8 hours

  2. Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)

    Time frame: 8 hours

  3. Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study title

OxxyneaGS: Single Blinded Randomized Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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