The Effect of the Inclusion of Soybean Flour on Glycemic Responses

The Effect of the Inclusion of Soybean Flour on Glycemic Responses of Bread, Tortilla, and Arepa to Enhance Human Nutrition

Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.

In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes.

Study Overview

• Status: Terminated
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Replacement of wheat flour by soyflour

Detailed Description

The purpose of this study is to compare different percentages of soy flour inclusion rates in recipes of bread, flour tortilla, and arepa (South American corn pancake) for its effect on satiation and glycemic and insulin responses.

The hypothesis to be tested is that soy flour inclusion will improve the protein content, satiety profile and glycemic response of the products without significant increases in insulin responses (compared to the same products prepared with regular wheat flour).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Champaign, Illinois, United States, 61820
      • University of Illinois at Urbana Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female between 21-45 years of age
• All races/ethnicities
• Body mass Index (BMI) > 25 kg/m2 and <40 kg/m2 (i.e., overweight and obesity, excluding severe obesity)
• Fat %: > 30% for female or > 20% for male

Exclusion Criteria:

• Currently smokes or quit smoking nicotine cigarettes, vapes or E-cigarettes for less than 6 months ago
• Pregnant, breastfeeding, menopausal
• Hemoglobin: <11g/dl for female and <13g/dl for male
• Blood donation in the past 8 weeks
• Gluten intolerance (Gluten allergy, wheat allergy, celiac disease), Soy intolerance or allergy
• Presence of malabsorption syndrome
• History of bariatric surgery
• Presence of inflammatory intestinal disease, liver, or kidney disease
• Diabetes (fasting glucose level >126mg/dl or plasma glucose level 2h after glucose challenge >200 mg/dl) or taking medicines to treat diabetes
• Polycystic ovary syndrome (pcos)
• Untreated hypertension
• Taking any medication that might affect glucose metabolism or the results of our study
• History of cancer <5 years ago
• Abnormalities in the metabolic panel test (e.g., liver enzymes >2 times the upper limit).
• Seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bread; Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)	Other: Replacement of wheat flour by soyflour; The intervention consist in replacing a fraction of wheat flour by soyflour
Experimental: Tortilla; Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)	Other: Replacement of wheat flour by soyflour; The intervention consist in replacing a fraction of wheat flour by soyflour
Experimental: Arepa; Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)	Other: Replacement of wheat flour by soyflour; The intervention consist in replacing a fraction of wheat flour by soyflour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Concentrations of glucose in plasma before and at different times post-prandially	-30 minutes to 120 min post-prandially
Plasma insulin	Concentrations of insulin in plasma before and at different times post-prandially	-30 minutes to 120 min post-prandially

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger-Satiety	Scores in the visual analog scales assessing hunger, fullness, the prospect of eating, etc	Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas)

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Kenneth Dallmier Consulting, LLC
• Investigators: Principal Investigator: Marta Y Pepino de Gruev, PhD, University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: insulin; satiety; glycemic responses
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 24388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No