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NCT Number: NCT07574008

Danish Pulses Meal Study

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.

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Key information

Conditions

LAB Fermentation in Pulses

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulses meal study

Dietary 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Inflammation CRP level

    Time frame: 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).

  2. Fasting Cholesterol

    Time frame: 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).

  3. Long-term blood glucose

    Time frame: 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).

  4. Blood pressure

    Time frame: 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.

  5. Body composition

    Time frame: 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.

  6. Fecal sample

    Time frame: 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.

  7. Dietary intake

    Time frame: 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.

  8. Digestive abnormalities

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Louise Almer, phD student

CONTACT

[email protected]

+45 72482258

Tenna Mie Christoffersen, ph.D

CONTACT

[email protected]

+45 72482246

Sponsors and collaborators

Lead sponsor

University College Absalon

Other

Registry information

Official study title

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

Acronym: Danish Pulses

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.