Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
9. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
27
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Berlin, Tyskland, 10369
- analyze & realize GmbH
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ralf Uebelhack, PhD, Charité
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2014
Primær fullføring (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
24. august 2015
Først innsendt som oppfylte QC-kriteriene
1. september 2015
Først lagt ut (Anslag)
4. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INQ/024613
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