Danish Pulses Meal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulses meal study, Pulses Meal Study.
- Who it may be relevant to
- Registry conditions: LAB Fermentation in Pulses. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Danish Pulses: Tasty, Healthy, and Safe Danish Pulses With Added Value for The Users
Overview
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.
Interventions
- Dietary supplement 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 - Dietary supplement 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 flou
Primary outcome measures
- Continuous glucose monitoring [Time frame: From day zero to 14 days and from day 14 to day 28]
Secondary outcome measures (8)
- Inflammation CRP level [Time frame: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
- Fasting Cholesterol [Time frame: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
- Long-term blood glucose [Time frame: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
- Blood pressure [Time frame: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).]
- Body composition [Time frame: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).]
- Fecal sample [Time frame: Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).]
- Dietary intake [Time frame: Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).]
- Digestive abnormalities [Time frame: Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- University College Absalon — Slagelse
Identifiers
NCT: NCT07574008 · SJ-1132-120770 · 34009-23-2191