Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
26 de outubro de 2020 atualizado por: Amanda Wright, Ph.D., University of Guelph
Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males
The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e.
crystalline) states.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend four study visits, separated by at least one week.
On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order.
All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature.
The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers.
This will isolate the impacts of physical state and acid stability, and their interactions.
Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage.
The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying.
It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of gastric emptying.
Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the four visits.
Tipo de estudo
Intervencional
Inscrição (Real)
15
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
Ontario
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Guelph, Ontario, Canadá, N1G 2W1
- University of Guelph
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- BMI of 18 - 26 kg/m2
- generally healthy
- non-smoking
- non to moderate alcohol drinkers
- fasting plasma cholesterol level <5.2 mmol/L
- plasma triacylglycerol level <1.7 mmol/L
- plasma glucose level <5.6 mmol/L
- no history of gastric surgeries
Exclusion Criteria:
- History of major medical conditions
- taking prescription medications/ over the counter medications
- taking natural health products/ dietary supplements (other than a multivitamin)
- oral antibiotic use in the previous 3 months
- planning to take oral antibiotics in the next 3 months
- food allergy/anaphylactic/life-threatening allergy
- smokers/ regular users of recreational drugs
- elite/ training athletes
- significant weight loss/ gain during the past 3 months
- previous reaction/ sensitivity to acetaminophen
- inability to avoid taking acetaminophen for 48 hours
- sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
- not willing to consume Sugar Twin® Sucralose or Artificial vanilla.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Acid stable emulsion with solid droplets
Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)
|
|
Experimental: Acid stable emulsion with liquid droplets
Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)
|
|
Experimental: Acid unstable emulsion with solid droplets
Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
|
Experimental: Acid unstable emulsion with liquid droplets
Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in triacylglycerol blood concentrations
Prazo: 6 hours
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Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
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6 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant visual analogue scale ratings of feelings of satiety
Prazo: 6 hours
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Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage.
0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated.
The distance from the left end of the scale will be measured (cm)
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6 hours
|
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Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations
Prazo: 6 hours
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The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)
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6 hours
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Changes in fatty acid concentration of blood triacylglycerols
Prazo: 6 hour
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Analysis based on fasting and postprandial blood sample analysis (mmol/L)
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6 hour
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Changes in satiety hormone blood concentrations
Prazo: 6 hours
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Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)
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6 hours
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Changes in concentrations of inflammatory blood markers (ug/mL)
Prazo: 6 hours
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Analysis of blood for CD14 and LBP at fasting and postprandially
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6 hours
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Rate of gastric emptying by measuring the change in the gastric antrum area
Prazo: 6 hours
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Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)
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6 hours
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Changes in glucose blood concentrations
Prazo: 6 hour
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Based on determination of fasting and postprandial blood glucose (mg/dL)
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6 hour
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hamad S, Tari NR, Mathiyalagan G, Wright AJ. Emulsion acid colloidal stability and droplet crystallinity modulate postprandial gastric emptying and short-term satiety: a randomized, double-blinded, crossover, controlled trial in healthy adult males. Am J Clin Nutr. 2021 Sep 1;114(3):997-1011. doi: 10.1093/ajcn/nqab116.
- Hamad S, Thilakarathna SH, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study. J Nutr. 2020 Sep 1;150(9):2295-2304. doi: 10.1093/jn/nxaa164.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de junho de 2019
Conclusão Primária (Real)
1 de março de 2020
Conclusão do estudo (Real)
31 de agosto de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
12 de junho de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de junho de 2019
Primeira postagem (Real)
18 de junho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 19-04-003
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .