- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT06898840
Ustanowienie wskaźnika glikemii napojów owocowych przy użyciu różnych metodologii pomiaru
Badanie w celu zbadania odpowiedzi glikemicznych na spożycie soków owocowych i koktajli przy użyciu różnych metodologii pomiaru.
Glycaemic responses to carbohydrates ingested as fruit sugars may vary depending on factors inherent to the fruit and the type of sugar. The aim of this project is to investigate the glycaemic responses to a range of commercially available fruit drinks and to establish the glycaemic index for each product relative to a glucose reference. Differences in recorded responses could also be influenced by the sample type (capillary blood vs interstitial fluid) and participant characteristics. Participants will ingest 8 test drinks including 5 different fruit drinks (OJ, AJ, S&B, ENERGISE, BLUE), each matched for carbohydrate to the glucose reference (CONTROL) which will be sampled two times, an additional sample of one of the smoothies (S&B) will also be replicated. Fingerstick capillary blood sampling alongside dual sited continuous glucose monitors (CGM) will measure glucose and lactate concentrations, subjective appetite sensations will also be recorded. The tests will follow best practice guidelines for glycaemic index testing. These data will provide insight into how differing formulations can alter the glycaemic responses to fruit drinks, and whether sampling technique can affect the interpretations of measurement.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Bath, Zjednoczone Królestwo, BA2 7AY
- Department for Health, University of Bath
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age: 18-65 years
- Body mass index 18-30 kg/m2
Exclusion Criteria:
- diagnosis of any form of diabetes
- intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
- Fructose malabsorption
- Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
- pregnant or lactating
- any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water |
Commercially available fruit drinks or smoothies |
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Aktywny komparator: REPLICATE CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water |
Commercially available fruit drinks or smoothies |
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Eksperymentalny: S&B
417 mL of commercially available "Strawberries & Bananas" fruit smoothie providing 50 g carbohydrate [strawberries (31%), apples, bananas (22%), white grapes, oranges, blackcurrants]. Plus 224 mL water to standardise volume |
Commercially available fruit drinks or smoothies |
|
Eksperymentalny: REPLICATE S&B
417 mL of commercially available "Strawberries & Bananas" fruit smoothie providing 50 g carbohydrate [strawberries (31%), apples, bananas (22%), white grapes, oranges, blackcurrants]. Plus 224 mL water to standardise volume |
Commercially available fruit drinks or smoothies |
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Eksperymentalny: OJ
641 mL of commercially available "Smooth Orange Juice" providing 50 g of carbohydrate [100% oranges] |
Commercially available fruit drinks or smoothies |
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Eksperymentalny: AJ
455 mL commercially available "Apple Juice" providing 50 g of carbohydrate [apples, ascorbic acid]. Plus 186 mL water to standardise volume |
Commercially available fruit drinks or smoothies |
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Eksperymentalny: ENERGISE
417 mL of commercially available "Energise Super Smoothie" providing 50 g carbohydrate [apples (50%), red grapes, bananas, strawberries (10%), blackcurrants, sour cherries (3.3%), pressed beetroot, flax seeds (0.56%), guarana infusion (0.01%), vitamins B1, B2, B3, B6, C & E]. Plus 224 mL water to standardise volume |
Commercially available fruit drinks or smoothies |
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Eksperymentalny: BLUE
521 mL of commercially available "Bolt from the Blue" juice drink providing 50 g carbohydrate [apple (66%), coconut water (18%), white grapes, white guava (5.2%), passion fruit, lime (0.87%), spirulina extract (0.81%) vitamins B1, B2, B3, B6, C & E]. Plus 120 mL water to standardise volume |
Commercially available fruit drinks or smoothies |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Glycaemic indices for 5 test drinks measured using capillary blood samples
Ramy czasowe: 120 minutes
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Glycaemic indices [2-hour incremental area under the glucose curve (mmol/L-1x120 minutes) for each of the 5 test drinks relative to mean value of control conditions (CONTROL, REPLICATE CONTROL), expressed as a percentage] in capillary blood samples |
120 minutes
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Glycaemic index of all conditions with capillary blood samples vs CGM
Ramy czasowe: 120 minutes
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The difference in glycaemic index [2-hour incremental area under the glucose curve (mmol/L-1x120 minutes) for 5 test drinks relative to mean control (CONTROL, REPLICATE CONTROL), expressed as a percentage] in capillary blood samples versus continuous glucose monitors. |
120 minutes
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Comparisons between conditions in glucose concentration in capillary samples
Ramy czasowe: 120 minutes
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Comparison of blood glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
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Comparisons between conditions in glucose concentration in capillary samples
Ramy czasowe: 120 minutes
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Comparison of postprandial peak concentration mmol/L of blood glucose between test conditions (Cmax) |
120 minutes
|
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Comparisons between conditions in glucose concentration in capillary samples
Ramy czasowe: 120 minutes
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Comparison of time to peak blood glucose concentration in minutes (Tmax) between test conditions |
120 minutes
|
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Comparisons between conditions in glucose concentration in capillary samples
Ramy czasowe: 120 minutes
|
Comparison of blood glucose concentration mmol/L at 2 hours between test conditions |
120 minutes
|
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Comparisons between conditions in glucose concentration with CGM
Ramy czasowe: 120 minutes
|
Comparison of glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
|
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Comparisons between conditions in glucose concentration with CGM
Ramy czasowe: 120 minutes
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Comparison of postprandial peak concentration mmol/L of glucose between test conditions (Cmax) |
120 minutes
|
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Comparisons between conditions in glucose concentration with CGM
Ramy czasowe: 120 minutes
|
Comparison of time to peak glucose concentration in minutes (Tmax) between test conditions |
120 minutes
|
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Comparisons between conditions in glucose concentration with CGM
Ramy czasowe: 120 minutes
|
Comparison of glucose concentration mmol/L at 2 hours between test conditions |
120 minutes
|
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Comparisons between conditions in lactate concentration in capillary samples
Ramy czasowe: 120 minutes
|
Comparison of blood lactate concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
|
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Comparisons between conditions in lactate concentration in capillary samples
Ramy czasowe: 120 minutes
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Comparison of postprandial peak concentration mmol/L of blood lactate between test conditions (Cmax) |
120 minutes
|
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Comparisons between conditions in lactate concentration in capillary samples
Ramy czasowe: 120 minutes
|
Comparison of time to peak blood lactate concentration in minutes (Tmax) between test conditions |
120 minutes
|
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Comparisons between conditions in lactate concentration in capillary samples
Ramy czasowe: 120 minutes
|
Comparison of blood lactate concentration mmol/L at 2 hours between test conditions |
120 minutes
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Comparisons between conditions of appetite ratings
Ramy czasowe: 120 minutes
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Comparison of subjective appetite sensations assessed with visual analogue scales (2-hour area under the curve min.mmVAS) |
120 minutes
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Comparisons between individuals
Ramy czasowe: 120 minutes
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Comparison of Postprandial lactate concentration min.mmol/L between individuals 2-hour incremental area under curve (iAUC) |
120 minutes
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Comparisons between individuals
Ramy czasowe: 120 minutes
|
Comparison of Postprandial glucose concentration min.mmol/L between individuals 2-hour incremental area under curve (iAUC) |
120 minutes
|
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Comparisons between individuals
Ramy czasowe: 120 minutes
|
Comparison of Appetite rating responses min.mmVAS between individuals 2-hour area under curve (AUC) |
120 minutes
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Comparisons within individuals
Ramy czasowe: 120 minutes
|
Comparison within individuals of interstitial glucose concentrations measurements from continuous glucose monitors on left and right arms. |
120 minutes
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 7134-9931
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
Ramy czasowe udostępniania IPD
These will become available at the point of publication permanently
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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