Legume Flour Particle Size and Metabolic Responses to Bread

NCT07716059 | Recruiting

• 1 other identifier: Γ-2941/02-07-2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

flour milling; legume seeds; Continuous glucose monitoring; particle size; T2DM; Subjective appetite sensations; postprandial glycemic response

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (2)

• 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.

  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

  0-180 mins

Study Arms (3)

Conventional White Bread exclusively prepared with 100% White flour

PLACEBO COMPARATOR

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.

Dietary Supplement: Conventional white wheat bread

Wheat bread in which 30% of white flour is substituted with finely milled chickpea flour

ACTIVE COMPARATOR

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.

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 flour

ACTIVE COMPARATOR

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.

Dietary Supplement: Wheat bread with 30% coarse chickpea flour

Interventions

Conventional white wheat bread DIETARY_SUPPLEMENT

Conventional white wheat bread providing 50 g of available carbohydrate

Conventional White Bread exclusively prepared with 100% White flour

Wheat bread with 30% finely milled chickpea flour DIETARY_SUPPLEMENT

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

Wheat bread in which 30% of white flour is substituted with finely milled chickpea flour

Wheat bread with 30% coarse chickpea flour DIETARY_SUPPLEMENT

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

Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flour

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (2)

Harokopio University

Athens, Attica, 17676, Greece

RECRUITING

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

Athens, Attica, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 40388189 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Maria Christina Kanata, MSc

CONTACT

+306937900141; mckanata@hua.gr

Amalia E Yanni, PhD

CONTACT

ayanni@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Acute single-blind controlled cross-over trial (RCT) with three test breads and a control bread.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 21, 2026
• Study Start: September 29, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)