The Effect of the Inclusion of Soybean Flour on Glycemic Responses (NCT06280625) | Clinical Trial Compass
TerminatedNot Applicable
The Effect of the Inclusion of Soybean Flour on Glycemic Responses
Stopped: We recruited and completed all 3 interventions in 10 participants for bread and 10 for tortilla, but stopped at 8 participants (instead of 10) for arepa and two of these participants only completed 2 out of 3 interventions because funding end.
United States17 participantsStarted 2024-03-11
Plain-language 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.
Who can participate
Age range
21 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.