The Effect of the Inclusion of Soybean Flour on Glycemic Responses

University of Illinois at Urbana-Champaign

Status: Terminated

Conditions: Overweight and Obesity

Treatments: Other: Replacement of wheat flour by soyflour

Study type: Interventional

Funder types: Other

Identifiers

NCT06280625

24388

Details and patient eligibility

About

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.

Full 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).

Enrollment: 17 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 3 patient groups

Bread

Experimental group

Description:

Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Treatment:

Other: Replacement of wheat flour by soyflour

Tortilla

Experimental group

Description:

Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Treatment:

Other: Replacement of wheat flour by soyflour

Arepa

Experimental group

Description:

Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Treatment:

Other: Replacement of wheat flour by soyflour