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Danish Pulses Meal Study (Danish Pulses)

1 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Tenna Mie Christoffersen, ph.D
  • Numero di telefono: +45 72482246
  • Email: tch@pha.dk

Backup dei contatti dello studio

  • Nome: Louise Almer, phD student
  • Numero di telefono: +45 72482258
  • Email: loua@pha.dk

Luoghi di studio

  • Danimarca
      • Slagelse, Danimarca, 4200
        • University College Absalon
        • Contatto:
          • Kim Daugaard
          • Numero di telefono: +45 72 482229
          • Email: kimd@pha.dk
        • Contatto:
          • Martin Smedegaard Vinvig
          • Numero di telefono: +45 72482261
          • Email: mavi@pha.dk
        • Investigatore principale:
          • Tenna Christoffersen, PhD
        • Sub-investigatore:
          • Louise Almer, PhD student

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Fermented pulses group 1
Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.
Integratore alimentare: 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.
Sperimentale: Unfermented pulses group 2
Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.
Integratore alimentare: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Continuous glucose monitoring
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Inflammation CRP level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University College Absalon

Investigatori

  • Direttore dello studio: Margit Dall Aaslyng, PhD, University College Absalon

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 settembre 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2026

Ultimo verificato

1 febbraio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • SJ-1132-120770
  • 34009-23-2191 (Altro numero di sovvenzione/finanziamento: Green Development and Demonstration Programme (GUDP))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Data are person-centered and ethical commitee requires no sharing.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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