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Type 2 DiabetesPULSENCT07716059

Legume Flour Particle Size and Metabolic Responses to Bread

A study testing Wheat bread with 30% finely milled chickpea flour, Conventional white wheat bread and Wheat bread with 30% coarse chickpea flour in people with Type 2 Diabetes, run by Harokopio University at 2 sites in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Wheat bread with 30% finely milled chickpea flour, Conventional white wheat bread and Wheat bread with 30% coarse chickpea flour
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
2 sitesGreece
Study dates
29 Sep 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Christina Kanata, MSc contact

+306937900141

mckanata@hua.gr

Amalia E Yanni, PhD contact

ayanni@hua.gr

Greece2 sites, 2 recruiting
  • Harokopio University

    Athens, Attica, 17676

    Amalia E Yanni, PhD, 2109549174, ayanni@hua.gr

    Recruiting
  • 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, 15772 Athens, Greece

    Athens, Attica

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Type 2 Diabetes
Being tested
Wheat bread with 30% finely milled chickpea flour, Conventional white wheat bread, Wheat bread with 30% coarse chickpea flour
Keywords
flour milling, legume seeds, Continuous glucose monitoring, particle size, T2DM, Subjective appetite sensations, postprandial glycemic response
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wheat bread with 30% finely milled chickpea flourDietary supplement

    Wheat bread formulated by replacing 30% of refined wheat flour with finely milled chickpea flour, providing 50 g of available carbohydrates

  • Conventional white wheat breadDietary supplement

    Conventional white wheat bread providing 50 g of available carbohydrate

  • Wheat bread with 30% coarse chickpea flourDietary supplement

    Wheat bread formulated by replacing 30% of refined wheat flour with coarse chickpea flour, providing 50 g of available carbohydrate.

Study groups in NCT07716059
Study groupRoleWhat they receive
Conventional White Bread exclusively prepared with 100% White flourPlacebo comparatorStudy 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.
Receives: Dietary Supplement: Conventional white wheat bread
Wheat bread in which 30% of white flour is substituted with finely milled chickpea flourActive comparatorStudy 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.
Receives: Dietary Supplement: Wheat bread with 30% finely milled chickpea flour
Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flourActive comparatorStudy 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.
Receives: Dietary Supplement: Wheat bread with 30% coarse chickpea flour

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 0-180 minutes postprandially.

Secondary outcomes (2)
  1. Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of bread enriched with 30% chickpea flour compared with white wheat bread.

    Postprandial blood glycemic response in healthy individuals, assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ minutes) using continuous glucose monitoring, following consumption of bread enriched with with 30% chickpea flour compared with white wheat bread.

    Measured: 0-180 minutes postprandially

  2. Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes) 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

    Postprandial blood glycaemic response in healthy individuals, as assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ minutes) 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 minutes postprandial period using the trapezoidal method, with baseline glucose defined as the mean glucose concentration during the 15 minutes prior to bread consumption.

    Measured: 0-180 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start29 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Acute single-blind controlled cross-over trial (RCT) with three test breads and a control bread.
Masking
Single blind
Who is masked
Participant
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716059
Sponsor's protocol ID
Γ-2941/02-07-2025
Acronym
PULSE
Status last verified
Nov 2025
First submitted
15 Jul 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are no plans to share individual participant data collected during this study.

Publications

  • Kanata MC, Yanni AE, Koliaki C, Anastasiou IA, Tentolouris N, Karathanos VT. Impact of flour particle size and origin on the bread structure and the postprandial glycemic, insulinemic and appetite responses in healthy adults. Food Funct. 2025 Jun 3;16(11):4548-4561. doi: 10.1039/d5fo00348b.

    PubMed 40388189

Questions about this trial

What is this clinical trial studying?

A study testing Wheat bread with 30% finely milled chickpea flour, Conventional white wheat bread and Wheat bread with 30% coarse chickpea flour in people with Type 2 Diabetes, run by Harokopio University at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Christina Kanata, MSc (+306937900141, mckanata@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread. (time frame: 0-180 minutes postprandially.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07716059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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