Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects (PRED)
11 décembre 2019 mis à jour par: Francisco Javier López Román, Universidad Católica San Antonio de Murcia
Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects
It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of Sclerocarya birrea).
It is a clinical trial, during which certain parameters of the glucidic metabolism will be measured analytically.
Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Murcia, Espagne, 30107
- Catholic University of Murcia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age: 18-65 years.
Diagnosis of prediabetes according to the American Diabetes Association.
- Altered fasting glucose (95-125 mg / dl).
- Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl).
- Hemoglobin glycated between 5.7 and 6.4%.
- Subjects with body mass index between 18-35 Kg / m2.
- Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks.
- I do not consume foods rich in Screrocaria Birrea.
Exclusion Criteria:
- Subjects with a history of any type of liver or kidney pathology.
- Use of medications that may interfere with glucose metabolism.
- Consumption of alcohol greater than 20 g / day.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study
- Lack of will or inability to comply with clinical trial procedures.
- Pregnancy.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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Expérimental: Sclerocarya birrea
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
endothelial function
Délai: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks
|
Changes in the dilatation of the Humeral artery.
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The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks
|
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blood samples
Délai: It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
|
Changes in glycemic profile
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It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
|
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Physical activity test
Délai: Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks
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Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
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Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks
|
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nutritional record
Délai: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Potential changes in the dietary survey were controlled with a food diary
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The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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body composition
Délai: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Changes in body composition were measured with a TANITA
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Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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glucose tolerance test
Délai: The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .
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Venous blood samples are taken from the finger at different times.
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The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .
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blood samples
Délai: It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl.
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It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2016
Achèvement primaire (Réel)
30 décembre 2018
Achèvement de l'étude (Réel)
4 janvier 2019
Dates d'inscription aux études
Première soumission
19 avril 2018
Première soumission répondant aux critères de contrôle qualité
16 octobre 2019
Première publication (Réel)
21 octobre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 décembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 décembre 2019
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UCAMCFE-0006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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