- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02650674
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
New South Wales
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Sydney, New South Wales, Austrália, 2006
- University of Sydney
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged between 18-45 years.
- Non-smoker.
- BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
- Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
- Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
- Healthy subjects with:
Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).
- Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
- Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
- Able to fast for at least 10 hours the night before each test session.
- Able to refrain from eating legumes and drinking alcohol the day before each test session.
- Subject covered by social security or covered by a similar system
- Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
- Subject having given written consent to take part in the study.
Exclusion Criteria:
- Following a restrictive diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
- Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
- Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
- Subject having taken part in another clinical trial within the last week.
- Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
- Subject undergoing general anaesthesia in the month prior to inclusion.
- Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Product A: NP-0148
Cereal product belVita Milk & Cereals - High in SDS
|
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
|
Experimental: Product B: NP-0149
Cereal product belVita Honey & Nuts - High in SDS
|
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
|
Experimental: Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
|
Experimental: Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
|
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
|
Experimental: Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
|
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
|
Experimental: Glucose reference
Glucose solution performed on three occasions
|
Glucose solution providing 50 g of available carbohydrates in 250 ml of water.
This will be performed 3 times
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Glycaemic index values of five cereal products
Prazo: 2 hours after food consumption
|
Determination of GI in both Caucasian and Asian subjects
|
2 hours after food consumption
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Prazo: 2 hours after food consumption
|
Determination of GI in the global population
|
2 hours after food consumption
|
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Glycaemic response assessed by the peak value of glycemia
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulinaemic response assessed by the peak value of insulinemia
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Kinetic of insulin / glucose over the 120 minutes
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Peak value of insulin / glucose ratio
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Delta peak value between baseline and peak values of insulin / glucose ratio
Prazo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennie Brand Miller, University of Sydney
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KBE043
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