The Effect of the Inclusion of Soybean Flour on Glycemic Responses

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280625
• Other study ID #: 24388
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 25, 2025

Study information

• Verified date: February 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Stephanie Okoye, PharmD
• Phone: 2173004709
• Email: siokoye2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 25, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Replacement of wheat flour by soyflour
The intervention consist in replacing a fraction of wheat flour by soyflour

Locations

Country	Name	City	State
United States	University of Illinois at Urbana Champaign	Champaign	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Kenneth Dallmier Consulting, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose	Concentrations of glucose in plasma before and at different times post-prandially	-30 minutes to 120 min post-prandially
Primary	Plasma insulin	Concentrations of insulin in plasma before and at different times post-prandially	-30 minutes to 120 min post-prandially
Secondary	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)