Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
9 novembre 2015 mis à jour par: InQpharm Group
Double-blind, Randomised, Placebo-controlled, Three-way Crossover Clinical Investigation to Evaluate the Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested.
The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
27
Phase
- Phase 3
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
-
-
-
Berlin, Allemagne, 10369
- analyze & realize GmbH
-
-
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 60 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Caucasian
- BMI between ≥ 25 and < 30 kg/m2
- Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
- Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
- Willing to maintain same level of physical activity during the study
- Willing to arrive at the study site with the same, non-strenuous means of transportation during the study
- Negative pregnancy testing (beta hCG) for women of childbearing potential during screening
- Women of child-bearing potential have to agree to use appropriate birth control methods during the study period
- Written informed consent of the subject to participate is a prerequisite for study participation
Exclusion Criteria:
- Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
- Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
- Use of anti-diabetic medication
- Strenuous exercise within one day prior to blood glucose sampling (including screening).
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Difficult veins
- Recent blood donation in the last 1 month prior to study
- Pregnancy or nursing
- Clinically relevant excursions of safety parameters
- Any other serious condition or disease that renders subjects ineligible
- Smoking
- Exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling
- All vegetarians and subjects with self-reported diet high in fat or protein
- Subjects are not able to communicate with local study staff
- Recent antibiotic and cortisone use up to one week and during the study
- Participation in another study during the last 30 days of the screening visit (V1)
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Dose 1 of IQP-VV-102
Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
|
Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
|
|
Comparateur actif: Dose 2 of IQP-VV-102
Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
|
Dose 2 (D2) group will take 4 tablets with active ingredients.
|
|
Comparateur placebo: Placebo
Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
|
Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects.
Délai: 120 minutes
|
Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
|
120 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in incremental PPG AUC level (mmol/L)
Délai: 120 minutes
|
Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
120 minutes
|
|
Change in total and incremental PPG AUC level (mmol/L)
Délai: 180 minutes
|
Measured from 0th minute, to 60th, 90th and 180th minute after intake of verum or placebo on subjects on each of the 3 visit days.
|
180 minutes
|
|
Changes in PPG concentration
Délai: 180 minutes
|
Measured at 15, 30, 45, 60, 90, and 120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
180 minutes
|
|
Dose response of PPG level
Délai: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
|
|
Change in total and incremental AUC insulin level (mmol/L)
Délai: 180 minutes
|
Measured from 0th minute to 120th and 180th minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
180 minutes
|
|
Dose response of insulin level
Délai: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
|
|
Change in total and incremental AUC triglyceride level
Délai: 180 minutes
|
Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
180 minutes
|
|
Global evaluation of tolerability both by investigator and subjects
Délai: Throughout the study (8-14 days)
|
Global scaled evaluation with "very good", "good", "moderate" and "poor"
|
Throughout the study (8-14 days)
|
|
Incidence of adverse events (Safety parameters evaluation)
Délai: Throughout the study period (8-14 days)
|
Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
|
Throughout the study period (8-14 days)
|
|
Reported adverse events
Délai: Throughout the whole study period (8-14 days)
|
For any adverse event, the term of the event, intensity, duration, seriousness, frequency, outcome and assessment of causality with the investigational product will be documented in the Case Report Form (CRF)
|
Throughout the whole study period (8-14 days)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ralf Uebelhack, PhD, Charité
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
1 juin 2014
Achèvement primaire (Réel)
1 octobre 2015
Dates d'inscription aux études
Première soumission
24 août 2015
Première soumission répondant aux critères de contrôle qualité
1 septembre 2015
Première publication (Estimation)
4 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 novembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2015
Dernière vérification
1 novembre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INQ/024613
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .