Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk (FitALA)
Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors
This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.
Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.
The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.
Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.
Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.
Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.
The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity. Additionally, study subjects are instructed to avoid walnuts and nuts other then study treatment, during the complete study period of 10 weeks.
Sample size calculation was conducted by use of online calculators, and was based on the low density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2 and 0.05, respectively, 62 subjects are needed.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Belgrade, Sérvia, 11000
- Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Presence of at least one of the following criteria, formerly assessed through routine medical examination:
- dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
- elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy
Exclusion Criteria:
- presence of allergy on any nuts
- presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
- smoking
- statin therapy
- pregnancy and/or lactation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Walnut
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm). Treatment arm includes 56 g of whole walnuts daily. |
Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner.
Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so.
Walnuts are provided with the same producer at the Belgrade market.
|
|
Sem intervenção: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in LDL-cholesterol
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in Systolic Blood Pressure
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in Diastolic Blood Pressure
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in HDL-cholesterol
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in total cholesterol
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in triglycerides
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in glucose metabolism biomarkers
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in renal function parameters
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in liver function parameters
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in body weight
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in waist circumference
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in percent of total body fat
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Level of Physical Activity
Prazo: Baseline
|
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
|
Baseline
|
|
Psychological parameters
Prazo: 5 weeks
|
Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
|
5 weeks
|
|
Changes in hematological parameters
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in number of leukocyte cells
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
|
Baseline, 5 weeks, 10 weeks
|
|
Changes in total caloric intake
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks. Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall. |
Baseline, 5 weeks, 10 weeks
|
|
Changes in caloric intake of fats
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks. The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall. |
Baseline, 5 weeks, 10 weeks
|
|
Changes in caloric intake of carbohydrates
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks. The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall. |
Baseline, 5 weeks, 10 weeks
|
|
Changes in caloric intake of vitamin D
Prazo: Baseline, 5 weeks, 10 weeks
|
Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks. The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall. |
Baseline, 5 weeks, 10 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Glibetic, Prof, Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- EO120/2017
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .