- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01393210
Beta-glucan and Insulin Sensitivity in Obese Humans
The Influence of Beta-glucan 1.3D-1.6D, Added to the Low-calorie Diet, on Insulin Sensitivity and the Expression of Selected Proinflammatory Cytokines in Adipose Tissue and Peripheral Blood Mononuclear Cells in Obese Humans
Obesity is an important health problem of modern civilization. In Western societies, almost half of the adult population has problems with an increased body weight. Products containing nutritional fiber has been used by humans for thousands of years. However, beta-glucan as biologically active compound, present in these products, has been identified relatively lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and 1,3D-1,4D.
Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the study was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on insulin sensitivity and the expression of selected proinflammatory cytokines in adipose tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose tolerance.
The study group consisted of 40 subjects with marked overweight or obesity (body mass index, BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after receiving a full information about the aim and the design of the study, were recruited.
At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators performed:
- anthropometric measurements.
- oral glucose tolerance test.
- euglycemic hyperinsulinemic clamp.
- PBMC isolation before and after the clamp.
- biopsy of subcutaneous adipose tissue before the clamp.
- isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected genes with the Real Time PCR was measured.
- After the initial visit, participants received detailed instructions about low-calorie diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14 days.
Then, participants were randomly assigned to a group receiving or not beta-glucan preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects. Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN 1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is indicated by the manufacturer.
After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performed at the beginning of the study were repeated.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Obesity is an important health problem of modern civilization. In Western societies, almost half of the adult population has problems with an increased body weight. In Europe, obesity occurs in 10-20% males and 15-25% females. In Poland, obesity is present in about 20% of population.
Products containing nutritional fiber has been used by humans for thousands of years. However, beta-glucan as biologically active compound, present in these products, has been identified relatively lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and 1,3D-1,4D.
Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. It stimulates host defense against viral, bacterial and parasitical infections through binding with the specific receptors located on the immune system cells surface in many animal models. There are data that beta-glucan 1,3D-1,6D affects both innate and acquired immune response also in humans.
The aim of the study was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on insulin sensitivity and the expression of selected proinflammatory cytokines in adipose tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose tolerance.
The study group consisted of 40 subjects with marked overweight or obesity (body mass index, BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after receiving a full information about the aim and the design of the study by the research personnel were recruited.
At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators assessed:
- anthropometric measurements: BMI, waist-to-hip ratio (WHR), full physical examination.
- body composition with Tanita TBF-511 Body Fat Analyzer.
- glucose tolerance with the oral glucose tolerance test.
- insulin sensitivity with the euglycemic hyperinsulinemic clamp technique.
- before and after the clamp, additional 6 ml of blood was collected, and PBMC isolation was performed.
- before the clamp, a biopsy of subcutaneous adipose tissue was performed.
- isolation of mRNA from PBMC and adipose tissue was performed. Then, the expression of the selected genes with the Real Time PCR In adipose tissue was measured measured.
- additionally, serum concentrations of ghrelin, peptide Y-Y3-36, citruline and intestinal fatty acid-binding protein was assessed.
After the initial visit, participants received detailed instructions about low-calorie diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14 days.
Then, participants were randomly assigned to a group receiving or not beta-glucan preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects. Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN 1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is indicated by the manufacturer.
Analysis of the compliance to the dietary indications and analysis of body composition was performed every 2 weeks.
After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performed at the beginning of the study were repeated.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Olsztyn, Polônia, 10-748
- Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- marked overweight or obesity (BMI above 28 kg/m2)
- normal glucose tolerance
Exclusion Criteria:
- morbid obesity (BMI above 40 kg/m2)
- impaired glucose tolerance or diabetes
- cardiovascular diseases
- other serious disease
- smoking
- usage of drugs known to affect carbohydrate or lipid metabolism
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: low-calorie diet
Intervention was low-calorie diet only for 12 weeks.
|
low-calorie diet only for 12 weeks.
|
|
Comparador Ativo: low calorie diet plus beta-glucan
Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D
500 mg daily for 12 weeks.
|
low-calorie diet only for 12 weeks.
beta-glucan 1.3D-1.6D,
together with a low calorie diet, 500 mg once daily for 12 weeks
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
insulin sensitivity
Prazo: one year
|
one year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
body weight
Prazo: one year
|
one year
|
|
amount of visceral adipose tissue
Prazo: one year
|
one year
|
|
expression of selected genes in PBMC and adipose tissue
Prazo: one year
|
one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marek Straczkowski, MD, prof., Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
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 (Estimativa)
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
- ZPChM-11-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .