Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects (PRED)
11 december 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
70
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Murcia, Spanien, 30107
- Catholic University of Murcia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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Experimentell: Sclerocarya birrea
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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endothelial function
Tidsram: 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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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
Tidsram: 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 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2016
Primärt slutförande (Faktisk)
30 december 2018
Avslutad studie (Faktisk)
4 januari 2019
Studieregistreringsdatum
Först inskickad
19 april 2018
Först inskickad som uppfyllde QC-kriterierna
16 oktober 2019
Första postat (Faktisk)
21 oktober 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 december 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 december 2019
Senast verifierad
1 december 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UCAMCFE-0006
Plan för individuella deltagardata (IPD)
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Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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Studerar en amerikansk FDA-reglerad produktprodukt
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