Clinical trial NCT06280625: The Effect of the Inclusion of Soybean Flour on Glycemic Responses
Official title: The Effect of the Inclusion of Soybean Flour on Glycemic Responses of Bread, Tortilla, and Arepa to Enhance Human Nutrition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: glycemic responses
insulin
satiety
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Kenneth Dallmier Consulting, LLC
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucose
timeFrame: -30 minutes to 120 min post-prandially
measure: Plasma insulin
timeFrame: -30 minutes to 120 min post-prandially
Secondary outcomes:
measure: Hunger-Satiety
timeFrame: Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas)
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois at Urbana Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Marta Y Pepino de Gruev, PhD
role: PRINCIPAL_INVESTIGATOR
References: