Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes

NCT07833527 | Not Yet Recruiting

• 2 other identifiers: 26-AKD-52126S321
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled. Each participant will attend two test sessions and will consume proso millet-based bread in one session and white wheat bread in the other. The order of the test breads will be randomized, and the two sessions will be separated by a one-week washout period. Each bread portion will provide 50 g of available carbohydrate. During each test session, the bread will be consumed within 10 minutes with 250 mL of water. Capillary blood glucose concentrations will be measured at predefined time points from baseline to 180 minutes after the start of consumption. Postprandial glycemic response will primarily be evaluated using the incremental area under the glucose response curve (iAUC). The study will investigate whether the postprandial glycemic response following consumption of proso millet-based bread differs from that following consumption of white wheat bread in adults with type 2 diabetes.

Conditions

Tip 2 Diabetes Mellitus

Keywords

Glycemic Response; Type 2 Diabetes Mellitus; Proso Millet; Millet-Based Bread; Postprandial Blood Glucose

Outcome Measures

Primary Outcomes (1)

• Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose

  The incremental area under the curve (iAUC) for capillary blood glucose will be calculated using the trapezoidal method based on glucose concentrations measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after consumption of each test bread. The iAUC will be compared between the proso millet-based bread and white wheat bread interventions.

  0 to 180 minutes after consumption of each test bread

Study Arms (2)

Sequence AB

EXPERIMENTAL

Participants will receive proso millet-based bread in the first intervention session, followed by white wheat bread in the second intervention session after a one-week washout period.

Other: Proso Millet-Based Bread; Other: White Wheat Bread

Sequence BA

EXPERIMENTAL

Participants will receive white wheat bread in the first intervention session, followed by proso millet-based bread in the second intervention session after a one-week washout period.

Other: Proso Millet-Based Bread; Other: White Wheat Bread

Interventions

Proso Millet-Based Bread OTHER

Participants will consume a portion of proso millet-based bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.

Sequence AB; Sequence BA

White Wheat Bread OTHER

Participants will consume a portion of white wheat bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 35 and 60 years Body mass index (BMI) ≥18.5 and ≤39.99 kg/m² Diagnosed with type 2 diabetes mellitus for at least 1 year Stable doses of antidiabetic medications for at least 3 months Cognitively capable of following dietary records and study instructions

You may not qualify if:

• Presence of atherosclerotic cardiovascular disease Malignancy Gastrointestinal disease Psychiatric disease Use of vitamin, mineral, or nutritional supplements Food allergy Following a weight-loss diet within the previous 3 months Regular consumption of millet (proso millet) Use of medications affecting carbohydrate metabolism Insulin therapy History of alcohol or substance dependence Major surgery within the previous 6 months Thyroid disease, including hypothyroidism or hyperthyroidism Engagement in high-intensity physical activity (e.g., professional athletes) Habitual consumption of a high-fiber diet Sleep disorder or night-shift work Antibiotic treatment Blood transfusion within the previous 3 months Presence of other endocrine disorders that may affect glucose metabolism Inability or unwillingness to comply with the study protocol Fasting capillary blood glucose at 0 minutes \<70 mg/dL or \>150 mg/dL, or HbA1c \>7.5% Heavy exercise within the previous 48 hours Current infection Smoking or alcohol consumption before the test session Caffeine consumption within the previous 24 hours Acute stress Use of medications that may affect blood glucose, such as corticosteroids or beta-blockers

Sponsors & Collaborators

• Gazi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Yasemin AKDEVELİOĞLU, PhD

  Gazi University

  STUDY CHAIR

• Mehmet M YALÇIN, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Şeyma Ş TAŞDEMİR, Research Assistant/PhD Student

CONTACT

+90 541 830 2166; sehadettasdemir@gmail.com

Study Design

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

Model Details: Participants will receive both the proso millet-based bread and the white wheat bread in two separate intervention sessions in a randomized order, with a one-week washout period between sessions. Each participant will serve as their own control.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share