Health Trials

Legume Flour Particle Size and Metabolic Responses to Bread

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarokopio University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • Conventional white wheat bread

    Dietary supplement

    Conventional white wheat bread providing 50 g of available carbohydrate

  • 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.

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Conventional White Bread exclusively prepared with 100% White flourPlacebo comparator 1 intervention
Group B: Wheat bread in which 30% of white flour is substituted with finely milled chickpea flourActive comparator 1 intervention
Group C: Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flourActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
0-180 minutes postprandially.

Secondary outcomes

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.

Time frame
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.

Time frame
0-180 minutes

Other outcomes

Sponsors and contacts

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Harokopio University

Lead sponsor

National and Kapodistrian University of Athens

Collaborator

Source ClinicalTrials.gov
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