LAB Fermentation in PulsesDanish PulsesNCT07574008
Danish Pulses Meal Study
A study testing Pulses meal study in people with LAB Fermentation in Pulses, run by University College Absalon at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- LAB Fermentation in Pulses
- What is being tested?
- Pulses meal study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No diabetes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
University College Absalon
Slagelse, 4200
Kim Daugaard, +45 72 482229, kimd@pha.dk
Martin Smedegaard Vinvig, +45 72482261, mavi@pha.dk
About this study
Official title: 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:
Read more
- 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.
- Conditions
- LAB Fermentation in Pulses
- Being tested
- Pulses meal study
- Keywords
- fermentation, lactic acid fermentation, meal study, legumes, pulses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulses meal studyDietary supplement
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.
Pulses Meal StudyDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Fermented pulses group 1 | Experimental | Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet. Receives: Dietary Supplement: Pulses meal study |
| Unfermented pulses group 2 | Experimental | Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet. Receives: Dietary Supplement: Pulses Meal Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose monitoring
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.
Measured: From day zero to 14 days and from day 14 to day 28
Secondary outcomes (8)
Inflammation CRP level
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).
Measured: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting Cholesterol
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).
Measured: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Long-term blood glucose
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).
Measured: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Blood pressure
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.
Measured: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Body composition
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.
Measured: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Fecal sample
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.
Measured: Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).
Dietary intake
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.
Measured: Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).
Digestive abnormalities
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).
Measured: Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LAB Fermentation in PulsesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel two-armed randomized trial. The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period), two weeks of LAB fermented foods, or two weeks of unfermented foods. The control period is from zero to 14 days, and after these two weeks, baseline data will be collected from all subjects. The second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of either fermented or unfermented legumes every day, seven days a week, for two weeks.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Absalon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margit Dall Aaslyng, PhD, Study director, University College Absalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574008
- Sponsor's protocol ID
- SJ-1132-120770
- Other IDs
- 34009-23-2191
- Acronym
- Danish Pulses
- Status last verified
- Feb 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are person-centered and ethical commitee requires no sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Pulses: Tasty, Healthy, and Safe Danish Pulses With Added Value for The Users
- ClinicalTrials.gov ID
- NCT07574008
- Acronym / sponsor ID
- Danish Pulses / SJ-1132-120770
- Conditions
- LAB Fermentation in Pulses
- Keywords
- fermentation, lactic acid fermentation, meal study, legumes, pulses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College AbsalonUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel two-armed randomized trial. The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period), two weeks of LAB fermented foods, or two weeks of unfermented foods. The control period is from zero to 14 days, and after these two weeks, baseline data will be collected from all subjects. The second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of either fermented or unfermented legumes every day, seven days a week, for two weeks.
| Arm | Type | Receives |
|---|---|---|
| Fermented pulses group 1 | Experimental | Dietary Supplement: Pulses meal studyParticipants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet. |
| Unfermented pulses group 2 | Experimental | Dietary Supplement: Pulses Meal StudyParticipants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No diabetes
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulses meal studyThe 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. | Dietary supplement | Fermented pulses group 1 |
| Pulses Meal StudyThe 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. | Dietary supplement | Unfermented pulses group 2 |
Primary outcome
Continuous glucose monitoring
Time frame: 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.
8 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Data are person-centered and ethical commitee requires no sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margit Dall Aaslyng, PhD study director
University College Absalon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulses meal study in people with LAB Fermentation in Pulses, run by University College Absalon at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tenna Mie Christoffersen, ph.D (+45 72482246, tch@pha.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose monitoring (time frame: From day zero to 14 days and from day 14 to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.