Overweight and Obesity
Conditions
Keywords
glycemic responses, insulin, satiety
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).
Interventions
OTHERReplacement of wheat flour by soyflour
The intervention consist in replacing a fraction of wheat flour by soyflour
Sponsors
Kenneth Dallmier Consulting, LLC
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %.
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. Participants will be allowed to be assessed in more than one food product (as they wish).
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed