Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Danish Pulses Meal Study (Danish Pulses)

1. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Tenna Mie Christoffersen, ph.D
  • Telefonní číslo: +45 72482246
  • E-mail: tch@pha.dk

Studijní záloha kontaktů

  • Jméno: Louise Almer, phD student
  • Telefonní číslo: +45 72482258
  • E-mail: loua@pha.dk

Studijní místa

  • Dánsko
      • Slagelse, Dánsko, 4200
        • University College Absalon
        • Kontakt:
          • Kim Daugaard
          • Telefonní číslo: +45 72 482229
          • E-mail: kimd@pha.dk
        • Kontakt:
          • Martin Smedegaard Vinvig
          • Telefonní číslo: +45 72482261
          • E-mail: mavi@pha.dk
        • Vrchní vyšetřovatel:
          • Tenna Christoffersen, PhD
        • Dílčí vyšetřovatel:
          • Louise Almer, PhD student

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Fermented pulses group 1
Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.
Doplněk stravy: 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.
Experimentální: Unfermented pulses group 2
Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.
Doplněk stravy: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Continuous glucose monitoring
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Inflammation CRP level
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University College Absalon

Vyšetřovatelé

  • Ředitel studie: Margit Dall Aaslyng, PhD, University College Absalon

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. září 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

1. května 2026

První předloženo, které splnilo kritéria kontroly kvality

1. května 2026

První zveřejněno (Aktuální)

7. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. května 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • SJ-1132-120770
  • 34009-23-2191 (Jiné číslo grantu/financování: Green Development and Demonstration Programme (GUDP))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Pulses meal study

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Armenia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit