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The Effect of the Inclusion of Soybean Flour on Glycemic Responses
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
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 28 February 2025
✅ Study Completion (Estimated) 25 March 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Champaign, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 February 2024
  • First Submitted that Met QC Criteria 20 February 2024
  • First Posted 28 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified February 2024
I'm interested ...!!