Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
9. november 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
27
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Berlin, Tyskland, 10369
- analyze & realize GmbH
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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 komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in incremental PPG AUC level (mmol/L)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ralf Uebelhack, PhD, Charité
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2014
Primær færdiggørelse (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først indsendt
24. august 2015
Først indsendt, der opfyldte QC-kriterier
1. september 2015
Først opslået (Skøn)
4. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INQ/024613
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .