Overweight and ObesityNCT06280625
The Effect of the Inclusion of Soybean Flour on Glycemic Responses
A study testing Replacement of wheat flour by soyflour in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Replacement of wheat flour by soyflour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana Champaign
Champaign, Illinois, 61820
About this study
Official title: The Effect of the Inclusion of Soybean Flour on Glycemic Responses of Bread, Tortilla, and Arepa to Enhance Human Nutrition
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.
Read the 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).
- Conditions
- Overweight and Obesity
- Being tested
- Replacement of wheat flour by soyflour
- Keywords
- glycemic responses, insulin, satiety
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replacement of wheat flour by soyflourOther
The intervention consist in replacing a fraction of wheat flour by soyflour
| Study group | Role | What they receive |
|---|---|---|
| Bread | Experimental | Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) Receives: Other: Replacement of wheat flour by soyflour |
| Tortilla | Experimental | Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) Receives: Other: Replacement of wheat flour by soyflour |
| Arepa | Experimental | Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) Receives: Other: Replacement of wheat flour by soyflour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Concentrations of glucose in plasma before and at different times post-prandially
Measured: -30 minutes to 120 min post-prandially
Plasma insulin
Concentrations of insulin in plasma before and at different times post-prandially
Measured: -30 minutes to 120 min post-prandially
Secondary outcomes (1)
Hunger-Satiety
Scores in the visual analog scales assessing hunger, fullness, the prospect of eating, etc
Measured: Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start11 Mar 2024
- Primary completion18 Jun 2025
- Study completion20 Jun 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Kenneth Dallmier Consulting, LLC
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino de Gruev, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280625
- Sponsor's protocol ID
- 24388
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Inclusion of Soybean Flour on Glycemic Responses of Bread, Tortilla, and Arepa to Enhance Human Nutrition
- ClinicalTrials.gov ID
- NCT06280625
- Acronym / sponsor ID
- 24388
- Conditions
- Overweight and Obesity
- Keywords
- glycemic responses, insulin, satiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Kenneth Dallmier Consulting, LLC
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Bread | Experimental | Other: Replacement of wheat flour by soyflourBread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) |
| Tortilla | Experimental | Other: Replacement of wheat flour by soyflourBread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) |
| Arepa | Experimental | Other: Replacement of wheat flour by soyflourArepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replacement of wheat flour by soyflourThe intervention consist in replacing a fraction of wheat flour by soyflour | Other | Arepa, Bread, Tortilla |
Primary outcome
Plasma glucose
Time frame: -30 minutes to 120 min post-prandially
Concentrations of glucose in plasma before and at different times post-prandially
Plasma insulin
Time frame: -30 minutes to 120 min post-prandially
Concentrations of insulin in plasma before and at different times post-prandially
1 secondary outcome
Hunger-Satiety
Time frame: Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Y Pepino de Gruev, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replacement of wheat flour by soyflour in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: -30 minutes to 120 min post-prandially). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.