Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
9 november 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
27
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Berlin, Duitsland, 10369
- analyze & realize GmbH
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
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Actieve vergelijker: 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.
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Dose 2 (D2) group will take 4 tablets with active ingredients.
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Placebo-vergelijker: Placebo
Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
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Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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.
Tijdsspanne: 120 minutes
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Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
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120 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in incremental PPG AUC level (mmol/L)
Tijdsspanne: 120 minutes
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Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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120 minutes
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Change in total and incremental PPG AUC level (mmol/L)
Tijdsspanne: 180 minutes
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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.
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180 minutes
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Changes in PPG concentration
Tijdsspanne: 180 minutes
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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.
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180 minutes
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Dose response of PPG level
Tijdsspanne: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Change in total and incremental AUC insulin level (mmol/L)
Tijdsspanne: 180 minutes
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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.
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180 minutes
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Dose response of insulin level
Tijdsspanne: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Change in total and incremental AUC triglyceride level
Tijdsspanne: 180 minutes
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Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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180 minutes
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Global evaluation of tolerability both by investigator and subjects
Tijdsspanne: Throughout the study (8-14 days)
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Global scaled evaluation with "very good", "good", "moderate" and "poor"
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Throughout the study (8-14 days)
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Incidence of adverse events (Safety parameters evaluation)
Tijdsspanne: Throughout the study period (8-14 days)
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Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
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Throughout the study period (8-14 days)
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Reported adverse events
Tijdsspanne: Throughout the whole study period (8-14 days)
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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)
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Throughout the whole study period (8-14 days)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ralf Uebelhack, PhD, Charité
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Werkelijk)
1 oktober 2015
Studieregistratiedata
Eerst ingediend
24 augustus 2015
Eerst ingediend dat voldeed aan de QC-criteria
1 september 2015
Eerst geplaatst (Schatting)
4 september 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
10 november 2015
Laatste update ingediend die voldeed aan QC-criteria
9 november 2015
Laatst geverifieerd
1 november 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- INQ/024613
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .