Effect of Tea Extract on Post Prandial Blood Glucose
This study is designed as a randomized, single blind (data evaluation), placebo controlled, full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥ 18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects will receive rice with a tea extract and rice without a tea extract.
There will be three visits to the test facility: one screening visit and two intervention visits. During the intervention visits venous blood samples will be collected for the analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).
Between the two intervention visits subjects have an interval of one week. This interval is required to minimize subject discomfort from repeated blood sampling.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Cork, Irland, T12 H2TK
- Atlantia Food Clinical Trials
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Waist circumference > 80 cm for women and > 94 cm for men;
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
- Fasting blood glucose value of subjects is ≥ 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening;
- Being physically inactive (meaning less than five times 30 minutes of moderate activity per week, or less than three times 20 minutes of vigorous activity per week, or equivalent);
Exclusion Criteria:
- Use of antibiotics within 3 months before first intake of test product;
- Use of any other medication except paracetamol, within 14 days before first intake of test product;
- Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week;
- Dislike, known allergy or intolerance to the treatments or other food products provided during the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Tea extract
Rice with tea extract
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Rice with tea extract
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|
Placebo komparator: No tea extract
Rice without tea extract
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Rice without tea extract
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incremental area under the plasma glucose versus time curve
Tidsramme: 0-2 hours
|
0-2 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incremental area under the plasma glucose versus time curve
Tidsramme: 0-3 hours
|
0-3 hours
|
|
Maximum venous glucose concentration
Tidsramme: 0-3 hours
|
0-3 hours
|
|
Total area under the post prandial insulin versus time curves
Tidsramme: 0-2 hours
|
0-2 hours
|
|
Total area under the post prandial insulin versus time curves
Tidsramme: 0-3 hours
|
0-3 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fergus Shanahan, Prof, Consultant gastroenterologist
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- REF-BEV-2731
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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