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Legume Flour Particle Size and Metabolic Responses to Bread (PULSE)

15. juli 2026 opdateret af: Amalia Yanni, Harokopio University

Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of partial replacement of wheat flour by legume flour of different particle sizes on postprandial glucose responses and appetite sensations in healthy subjects and patients with type 2 diabetes.

Subjects will consume a portion of bread enriched with legume flours yielding 50 g of available carbohydrates as breakfast meal. To investigate the effect of the bread on glycemic response, a continuous glucose monitoring system (CGM) will be used. After an 180-min period, subjects will be given a second meal and glycemic response will be monitored for another 180 min. During the trial subjects must fill appropriate visual analogue scales regarding appetite sensations.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The clinical trial will include two groups: (a) apparently healthy adults (up to 35 years old) and (b) individuals diagnosed with T2DM (aged 40-65 years). The study will investigate the effect of flour particle size on postprandial glycemic responses to bread and appetite sensations.

Within the framework of the clinical study, a total of three bread products will be prepared. Their final recipes will be determined after a series of tests to ensure the desired properties and organoleptic characteristics.

Intervention 1: White wheat bread with conventional fine wheat flour Intervention 2: White wheat bread with the addition of 30% finely milled chickpea flour Intervention 3: White wheat bread with the addition of 30% chickpea flour of larger particle size (>1.6 mm)

Inclusion and Exclusion Criteria

  1. Group 1

    Participants in Group 1 will be men and women aged 40-65 years with BMI < 31 kg/m², fasting glucose > 125 mg/dL, and HbA1c < 8.5%, diagnosed with T2DM for at least one year before entering the study.

    Patients must be on stable treatment (hypoglycemic, lipid-lowering, antihypertensive) for at least 3 months prior to enrolment. Most participants will be individuals monitored at the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine at Laiko General Hospital.

    Individuals with conditions that could affect study outcomes (e.g., endocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders), those with sensitivity, intolerance, or allergy to any bread ingredients used in the clinical trial, pregnant or breastfeeding women, individuals with eating disorders, and those taking medications or supplements considered incompatible with the study will be excluded.

  2. Group 2

Group 2 will consist of apparently healthy men and women aged 18-35 years with BMI 18-25 kg/m², who are not following a diet program or dietary counseling during the study period.

Individuals with fasting glucose > 110 mg/dL, blood pressure > 160/100 mmHg, metabolic or dietary disorders, conditions that could affect the study outcomes (e.g., endocrine, cardiovascular, pulmonary, renal, or gastrointestinal diseases), those with sensitivity, intolerance, or allergy to the bread ingredients used, pregnant or breastfeeding women, and those taking medications that could affect the study (e.g., hypoglycemic drugs, appetite-modifying medications, or any other relevant medications) will be excluded.

All volunteers, after providing informed written consent, will undergo a blood sample collection to confirm eligibility based on defined criteria, as well as for additional hematological and biochemical analyses. Subsequently, each participant will have a Continuous Glucose Monitoring (CGM) sensor placed by trained personnel according to the manufacturer's instructions, in order to monitor glucose values throughout the postprandial protocol. Measurements will include the period following consumption of the first meal (bread) and a second standardized meal, consumed 3 h later.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Maria Christina Kanata, MSc
  • Telefonnummer: +306937900141
  • E-mail: mckanata@hua.gr

Undersøgelse Kontakt Backup

Studiesteder

  • Grækenland
    • Attica
      • Athens, Attica, Grækenland, 17676
        • Rekruttering
        • Harokopio University
        • Kontakt:
          • Amalia E Yanni, PhD
          • Telefonnummer: 2109549174
          • E-mail: ayanni@hua.gr
      • Athens, Attica, Grækenland
        • Rekruttering
        • 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, 15772 Athens, Greece

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Cohort Healthy Participants

Inclusion Criteria:

  • Age: Adults aged 18-35 years.
  • Health Status: Healthy individuals with no diagnosed chronic diseases, including diabetes, cardiovascular disease, or gastrointestinal disorders.
  • Body Mass Index (BMI): 18.5-27 kg/m² (normal to overweight range).
  • Fasting Glucose: Normal fasting plasma glucose (<100 mg/dL or <5.6 mmol/L).
  • No regular use of medications known to affect glucose metabolism (e.g., insulin, metformin, corticosteroids).
  • Ability and willingness to comply with study procedures, including continuous glucose monitoring and standardized test meals.
  • Informed Consent: Ability to understand and provide written informed consent.

Exclusion Criteria:

  • Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease, kidney or liver disease, gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease).
  • Abnormal glucose metabolism: Fasting plasma glucose ≥100 mg/dL (≥5.6 mmol/L) or HbA1c ≥5.7%.
  • Medication use: Regular use of medications that affect glucose metabolism, insulin sensitivity, or digestion (e.g., metformin, corticosteroids, GLP-1 analogs).
  • Allergies or intolerances: Allergy or intolerance to wheat, chickpeas, gluten, or other ingredients used in the study foods.
  • Pregnancy or lactation: Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
  • Recent major weight change: Significant weight loss or gain (>5% body weight) in the past 3 months.
  • Extreme physical activity: Competitive athletes or individuals engaging in extreme exercise regimens that could influence glucose metabolism.
  • Inability to comply: Individuals unable or unwilling to follow study procedures, including continuous glucose monitoring and standardized test meals.

Cohort 2: Participants with Type 2 Diabetes Mellitus

Men and women aged 40-75 years. Body mass index (BMI) < 31 kg/m². Fasting plasma glucose > 125 mg/dL. HbA1c < 8.5%. Diagnosis of type 2 diabetes mellitus (T2DM) for at least 1 year before enrolment.

Stable treatment with hypoglycaemic, lipid-lowering, and/or antihypertensive medications for at least 3 months prior to enrolment.

Most participants will be recruited from the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine, Laiko General Hospital.

Exclusion criteria

Endocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders that could affect study outcomes.

Sensitivity, intolerance, or allergy to any ingredients of the study breads. Pregnancy or breastfeeding. Eating disorders. Use of medications or dietary supplements considered incompatible with the study protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Conventional White Bread exclusively prepared with 100% White flour
Study participants will consume a single serving of refined white wheat bread prepared from finely milled flour, providing 50 g of available carbohydrate, and served as a control test meal under controlled conditions.
Kosttilskud: Conventional white wheat bread
Conventional white wheat bread providing 50 g of available carbohydrate
Aktiv komparator: Wheat bread in which 30% of white flour is substituted with finely milled chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with finely milled chickpea flour, providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Kosttilskud: Wheat bread with 30% finely milled chickpea flour
Wheat bread formulated by replacing 30% of refined wheat flour with finely milled chickpea flour, providing 50 g of available carbohydrates
Aktiv komparator: Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with larger particle size chickpea flour providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Kosttilskud: Wheat bread with 30% coarse chickpea flour
Wheat bread formulated by replacing 30% of refined wheat flour with coarse chickpea flour, providing 50 g of available carbohydrate.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.
Tidsramme: 0-180 minutes postprandially.

For the study in healthy subjects a sample size of 20 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 20% in postprandial glycemia.

For the study in diabetic patients a sample size of 14 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 30% in postprandial glycemia.
0-180 minutes postprandially.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of bread enriched with 30% chickpea flour compared with white wheat bread.
Tidsramme: 0-180 minutes postprandially
Postprandial blood glycemic response in healthy individuals, assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ min) using continuous glucose monitoring, following consumption of bread enriched with with 30% chickpea flour compared with white wheat bread.
0-180 minutes postprandially
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with bread enriched with 30% refined chickpea flour
Tidsramme: 0-180 mins
Postprandial blood glycaemic response in healthy individuals, as assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ min) measured by continuous glucose monitoring following consumption of bread enriched with 30% larger particle size chickpeas compared with bread enriched with 30% refined chickpea flour. Glucose concentrations will be recorded continuously, and iAUC will be calculated over the 0-180 min postprandial period using the trapezoidal method, with baseline glucose defined as the mean glucose concentration during the 15 min prior to bread consumption.
0-180 mins

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Harokopio University

Samarbejdspartnere

National and Kapodistrian University of Athens

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. september 2025

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. november 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Γ-2941/02-07-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There are no plans to share individual participant data collected during this study.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kosttilskud

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Placeringer

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