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Danish Pulses Meal Study (Danish Pulses)

2026年5月1日更新者：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.

研究概览

地位

尚未招聘

条件

LAB Fermentation in Pulses

干预/治疗

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Tenna Mie Christoffersen, ph.D
电话号码：+45 72482246
邮箱：tch@pha.dk

研究联系人备份

姓名：Louise Almer, phD student
电话号码：+45 72482258
邮箱：loua@pha.dk

学习地点

丹麦
- - Slagelse、丹麦、4200
    - University College Absalon
    - 接触：
      
      Kim Daugaard
      
      电话号码：+45 72 482229
      
      邮箱：kimd@pha.dk
    - 接触：
      
      Martin Smedegaard Vinvig
      
      电话号码：+45 72482261
      
      邮箱：mavi@pha.dk
    - 首席研究员：
      
      Tenna Christoffersen, PhD
    - 副研究员：
      
      Louise Almer, PhD student

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Fermented pulses group 1 Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.	膳食补充剂：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.
实验性的：Unfermented pulses group 2 Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.	膳食补充剂：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.

参与者组/臂

干预/治疗

实验性的：Fermented pulses group 1

Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.

膳食补充剂：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.

实验性的：Unfermented pulses group 2

Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.

膳食补充剂：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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Continuous glucose monitoring 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Inflammation CRP level 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University College Absalon

调查人员

研究主任：Margit Dall Aaslyng, PhD、University College Absalon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月10日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月1日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年5月1日

最后验证

2026年2月1日

Danish Pulses Meal Study (Danish Pulses)

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

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

研究联系人备份

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

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关键字

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计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

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