The Effect of the Inclusion of Soybean Flour on Glycemic Responses

NCT06280625 | Terminated

• 1 other identifier: 24388
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

glycemic responses; insulin; satiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Hunger-Satiety

  Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas)

Study Arms (3)

Bread

EXPERIMENTAL

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

Tortilla

EXPERIMENTAL

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

Arepa

EXPERIMENTAL

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

Interventions

Replacement of wheat flour by soyflour OTHER

The intervention consist in replacing a fraction of wheat flour by soyflour

Arepa; Bread; Tortilla

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Kenneth Dallmier Consulting, LLC: collaborator

Study Sites (1)

University of Illinois at Urbana Champaign

Champaign, Illinois, 61820, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Marta Y Pepino de Gruev, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: People will be evaluated with a food product prepared with different % of replacement of wheat flour for soy flour. Each person will be their own control. In other words, in randomized order, they will all be assessed with the food product prepared with the regular wheat flour (either bread, tortillas or arepas) and on two other visits with different percentages of soy flour. Participants will be allowed to be assessed in more than one food product (as they wish).

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 11, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 20, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)