Установление гликемического индекса фруктовых напитков с использованием различных методологий измерения
Изучите, чтобы исследовать гликемические реакции на проглатывание фруктовых соков и смузи, используя различные методологии измерения.
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Bath, Соединенное Королевство, BA2 7AY
- Department for Health, University of Bath
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water |
Commercially available fruit drinks or smoothies |
|
Активный компаратор: REPLICATE CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water |
Commercially available fruit drinks or smoothies |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Экспериментальный: OJ
641 mL of commercially available "Smooth Orange Juice" providing 50 g of carbohydrate [100% oranges] |
Commercially available fruit drinks or smoothies |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Glycaemic indices for 5 test drinks measured using capillary blood samples
Временное ограничение: 120 minutes
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Glycaemic index of all conditions with capillary blood samples vs CGM
Временное ограничение: 120 minutes
|
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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Comparisons between conditions in glucose concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of blood glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of blood glucose between test conditions (Cmax) |
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of time to peak blood glucose concentration in minutes (Tmax) between test conditions |
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of blood glucose concentration mmol/L at 2 hours between test conditions |
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Временное ограничение: 120 minutes
|
Comparison of glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Временное ограничение: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of glucose between test conditions (Cmax) |
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Временное ограничение: 120 minutes
|
Comparison of time to peak glucose concentration in minutes (Tmax) between test conditions |
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Временное ограничение: 120 minutes
|
Comparison of glucose concentration mmol/L at 2 hours between test conditions |
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of blood lactate concentration 2-hour incremental area under the curve (iAUC) min.mmol/L between test conditions |
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of blood lactate between test conditions (Cmax) |
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of time to peak blood lactate concentration in minutes (Tmax) between test conditions |
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Временное ограничение: 120 minutes
|
Comparison of blood lactate concentration mmol/L at 2 hours between test conditions |
120 minutes
|
|
Comparisons between conditions of appetite ratings
Временное ограничение: 120 minutes
|
Comparison of subjective appetite sensations assessed with visual analogue scales (2-hour area under the curve min.mmVAS) |
120 minutes
|
|
Comparisons between individuals
Временное ограничение: 120 minutes
|
Comparison of Postprandial lactate concentration min.mmol/L between individuals 2-hour incremental area under curve (iAUC) |
120 minutes
|
|
Comparisons between individuals
Временное ограничение: 120 minutes
|
Comparison of Postprandial glucose concentration min.mmol/L between individuals 2-hour incremental area under curve (iAUC) |
120 minutes
|
|
Comparisons between individuals
Временное ограничение: 120 minutes
|
Comparison of Appetite rating responses min.mmVAS between individuals 2-hour area under curve (AUC) |
120 minutes
|
|
Comparisons within individuals
Временное ограничение: 120 minutes
|
Comparison within individuals of interstitial glucose concentrations measurements from continuous glucose monitors on left and right arms. |
120 minutes
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 7134-9931
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Сроки обмена IPD
These will become available at the point of publication permanently
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .