The Effect of the Inclusion of Soybean Flour on Glycemic Responses

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Other: Replacement of wheat flour by soyflour

• Registration Number: NCT06280625
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bread	Replacement of wheat flour by soyflour	Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
Arepa	Replacement of wheat flour by soyflour	Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
Tortilla	Replacement of wheat flour by soyflour	Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Primary Outcome Measures

Name	Time	Method
Plasma glucose	-30 minutes to 120 min post-prandially	Concentrations of glucose in plasma before and at different times post-prandially
Plasma insulin	-30 minutes to 120 min post-prandially	Concentrations of insulin in plasma before and at different times post-prandially

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois at Urbana Champaign; 🇺🇸 Champaign, Illinois, United States