Danish Pulses Meal Study

NCT07574008 | Not Yet Recruiting

• 2 other identifiers: SJ-1132-12077034009-23-2191
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

fermentation; lactic acid fermentation; meal study; legumes; pulses

Outcome Measures

Primary Outcomes (1)

• 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.

  From day zero to 14 days and from day 14 to day 28

Secondary Outcomes (8)

• Inflammation CRP level

  Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).

• Fasting Cholesterol

  Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).

• Long-term blood glucose

  Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).

• Blood pressure

  Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).

• Body composition

  Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).

Study Arms (2)

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.

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.

Dietary Supplement: Pulses Meal Study

Interventions

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.

Fermented pulses group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No diabetes

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Absalon: lead

Study Sites (1)

University College Absalon

Slagelse, 4200, Denmark

Location

Study Officials

• Margit Dall Aaslyng, PhD

  University College Absalon

  STUDY DIRECTOR

Central Study Contacts

Tenna Mie Christoffersen, ph.D

CONTACT

+45 72482246; tch@pha.dk

Louise Almer, phD student

CONTACT

+45 72482258; loua@pha.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible to mask the intervention, as unfermented and fermented pulses are easy to see.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)