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Danish Pulses Meal Study (Danish Pulses)

1 de maio de 2026 atualizado por: University College Absalon

Danish Pulses: Tasty, Healthy, and Safe Danish Pulses With Added Value for The Users

The goal of this clinical trial is to learn whether daily intake of lactic acid bacteria fermented or unfermented legumes can improve metabolic and gut health in healthy adults.

The main questions it aims to answer are:

  • Does eating 100 g per day of legumes for 2 weeks lower blood glucose, measured primarily by continuous glucose monitoring, compared with a control period of habitual diet?
  • Does eating 100 g per day of legumes for 2 weeks improve inflammation, cholesterol, gut microbiome composition, and short-chain fatty acid (SCFA) levels, and do fermented legumes have additional effects on body composition compared with unfermented legumes? Researchers will compare participants consuming LAB-fermented legumes with participants consuming unfermented legumes to see if fermented legumes produce greater health benefits, particularly for body composition and other metabolic outcomes.

Participants will:

  • Follow their habitual diet for 14 days during a control period.
  • Complete baseline measurements after the control period.
  • Be randomly assigned to consume 100 g per day of either LAB-fermented or unfermented legumes for 14 days.
  • Eat the provided standardized legume foods as part of their usual meals.
  • Undergo continuous glucose monitoring and other assessments, incl. inflammation, cholesterol, long-term blood glucose, blood pressure, body composition, fecal microbiome, dietary intake, and digestive symptoms.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

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.

Contato de estudo

  • Nome: Tenna Mie Christoffersen, ph.D
  • Número de telefone: +45 72482246
  • E-mail: tch@pha.dk

Estude backup de contato

  • Nome: Louise Almer, phD student
  • Número de telefone: +45 72482258
  • E-mail: loua@pha.dk

Locais de estudo

  • Dinamarca
      • Slagelse, Dinamarca, 4200
        • University College Absalon
        • Contato:
          • Kim Daugaard
          • Número de telefone: +45 72 482229
          • E-mail: kimd@pha.dk
        • Contato:
          • Martin Smedegaard Vinvig
          • Número de telefone: +45 72482261
          • E-mail: mavi@pha.dk
        • Investigador principal:
          • Tenna Christoffersen, PhD
        • Subinvestigador:
          • Louise Almer, PhD student

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

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • No diabetes

Exclusion Criteria:

  • Treatment with antibiotics within the last three months.
  • Ongoing treatment with non-steroidal anti-inflammatory drugs.
  • Metabolic diseases, including diabetes.
  • Inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis.
  • Allergies or intolerance to legumes.
  • People that report eating > 25 g per day of legumes as part of their habitual diet.

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Fermented pulses group 1
Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.
Suplemento dietético: Pulses meal study
The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of lactic acid fermented pulses every day, seven days a week, for two weeks. Fermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume flour, adding up to 100 g of legumes per day. These test foods can be eaten throughout the day; however, intake of other legumes, except those included in the foods, should be avoided.
Experimental: Unfermented pulses group 2
Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.
Suplemento dietético: Pulses Meal Study
The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of unfermented pulses every day, seven days a week, for two weeks. The unfermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume flour, adding up to 100 g of legumes per day. These test foods can be eaten throughout the day; however, intake of other legumes, except those included in the foods, should be avoided.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Continuous glucose monitoring
Prazo: From day zero to 14 days and from day 14 to day 28
Continuous Glucose Monitoring (CGM) will be measured in real-time and intermittently scanned CGM (isCGM) bi-weekly with an isCGM sensor (model Abbott Freestyle Libre PRO). This method is a minimally invasive method, as the sensor is placed on the participant's arm (26-30), by participants themselves after careful instructions, incl. videos. The Abbott Freestyle Libre PRO is blinded to the participants to avoid habitual changes, and it measures CGM in real-time throughout the entire 14-day period. The study follows the Standardized CGM metrics for Clinical Care, and the 14-day duration is aligned with the international recommendations (26,30). To ensure accurate and meaningful interpretation of CGM, adequate glucose data is collected according to the recommendation (70% of data from 14 days) (26,30). Data from participants with a CGM activity < 70% will be analyzed with the intention to treat principles.
From day zero to 14 days and from day 14 to day 28

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Inflammation CRP level
Prazo: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting C-reactive proteins (CRP) monitoring will be measured at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting Cholesterol
Prazo: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting cholesterol monitoring will be conducted at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Long-term blood glucose
Prazo: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting hemoglobin A1c (HbA1c) monitoring will be conducted at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Blood pressure
Prazo: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Systolic and diastolic blood pressures will be measured at baseline, day 14, and at day 28. Blood pressures will be measured in millimeters of mercury using an automatic blood pressure monitor (Digital Automatic Blood Pressure Monitor, Omron). Participants will be asked to lie down and relax for approximately 8 to 10 minutes, and 3 blood pressure measurements will be recorded at 5-minute intervals.
Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Body composition
Prazo: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).

Anthropometric measurements, will be measured by a Body Impedance Analytics (BIA) (TANITA MC 780 MA S, Japan).

Height (m) will be measured using a standard dynamometer without shoes and is recorded to the nearest 0.1 cm.

Body mass index (BMI) is calculated by dividing weight (kg) by height (m) squared (kg/m2).

Waist and hip circumferences will be measured using a standardized tape measure that is calibrated before use. Waist circumference (cm) will be measured at the midpoint between the lowest rib and the upper part of the iliac bone in a standing position. Hip circumference (cm) will be measured at the site of the largest circumference between the waist and thighs.
Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Fecal sample
Prazo: Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).
Fecal samples (approximately 10 g) will be collected from all participants. Participants are collecting the samples by themselves using the EasySampler tool kit, including a thorough written introduction(33,34). Fecal pH will be determined by mixing fecal matter 1:2 with sterile MilliQ-water after which pH is measured. Total fecal DNA will be extracted using standard methods. The gut microbial metagenome will be determined by shotgun high-throughput sequencing using long-read Oxford Nanopore-based sequencing. Before any further bioinformatics processing the raw reads will be purged of any human DNA-related sequences.. Fecal short chain fatty acids and other fecal metabolite concentrations, incl. free amino acids, are determined using high-field nuclear magnetic resonance NMR on fecal samples.
Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).
Dietary intake
Prazo: Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).

Data on dietary intake will be collected by three-day dietary records with photos to evaluate adherence to the intervention. The dietary records will be collected once during the control period and once during the intervention period. Photos will be used for main meals and leftovers of legumes.

Physical activity will also be documented as part of the dietary records and used to estimate energy expenditure. Furthermore, data on dietary intake will be used to assess compliance with the intervention.
Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).
Digestive abnormalities
Prazo: Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).
Digestive abnormalities are identified through IBS symptoms and will be assessed using self-reported questionnaires using the IBS Severity Scoring System (IBS-SSS) for assessment of the following symptoms: abdominal distension, abdominal pain, satisfaction with bowel habits, and the extent to which symptoms affect the quality of life (QoL).
Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University College Absalon

Investigadores

  • Diretor de estudo: Margit Dall Aaslyng, PhD, University College Absalon

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 (Estimado)

10 de setembro de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de maio de 2026

Primeira postagem (Real)

7 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de maio de 2026

Última verificação

1 de fevereiro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • SJ-1132-120770
  • 34009-23-2191 (Número de outro subsídio/financiamento: Green Development and Demonstration Programme (GUDP))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Data are person-centered and ethical commitee requires no sharing.

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 .

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