Soy Flour for Obesity

Overseen By Marta Y Pepino de Gruev, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Must not be taking: Diabetes medications

Disqualifiers: Smoking, Pregnancy, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day per product

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how soy flour in bread, tortillas, and arepas might reduce blood sugar spikes and improve feelings of fullness. Foods that cause quick blood sugar increases can lead to issues like diabetes and obesity. By replacing some wheat flour with soy flour, the researchers aim to determine if this change offers better nutrition and helps maintain stable blood sugar levels. The trial seeks participants who are overweight but not severely obese and do not have diabetes or food allergies related to gluten or soy. As an unphased trial, it offers a unique opportunity to contribute to nutritional research that could benefit many people in the future.

Will I have to stop taking my current medications?

The trial requires that you do not take any medication that might affect glucose metabolism or the results of the study. If you are on such medications, you may need to stop them to participate.

What prior data suggests that soy flour is safe for human consumption?

Research has shown that soybean flour is generally safe to eat. One study tested soybean products on older adults with obesity and found they tolerated them well, with no major side effects reported in this small group. Soybean flour is already used in many foods, and the amount used in these trials matches what is typically found in diets.

However, people with soy allergies should avoid soy products, as even small amounts can cause reactions. Overall, evidence suggests that adding soy flour to foods like bread, tortillas, and arepas is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using soybean flour to tackle obesity because it offers a natural, plant-based alternative to conventional treatments like medications and surgical interventions. Unlike typical obesity treatments that may involve pharmaceuticals with potential side effects, soybean flour is integrated into everyday foods like bread, tortillas, and arepas, making it an innovative dietary approach. This method not only provides a healthier option but also encourages sustainable eating habits by replacing some wheat flour with soy flour, potentially offering nutritional benefits and aiding in weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that soy flour might aid in managing weight and obesity. For example, one study found that diets with soy can promote weight loss because soy is high in fiber, which increases satiety. Another study discovered that consuming soy can significantly reduce waist size in older adults. This trial will test different soy flour concentrations in various foods, such as bread, tortillas, and arepas, to evaluate their effects on weight management. Although one study found that soy-enriched bread didn't significantly change body measurements or blood pressure, other evidence supports the idea that soy can enhance satiety and aid in weight control. Additionally, consuming soy has been linked to lower obesity rates by improving diet quality. ^{6 7 8 9 10}

Who Is on the Research Team?

Marta Y Pepino de Gruev, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Are You a Good Fit for This Trial?

This trial is for individuals who are dealing with obesity. It's designed to see if replacing some wheat flour with soy flour in their diet can help manage blood sugar levels and increase feelings of fullness after eating.

Inclusion Criteria

Body mass Index (BMI) > 25 kg/m2 and <40 kg/m2 (i.e., overweight and obesity, excluding severe obesity)

All races/ethnicities

Fat %: > 30% for female or > 20% for male

Exclusion Criteria

I am not on medication that affects blood sugar or could interfere with the study.

Blood donation in the past 8 weeks

Gluten intolerance (Gluten allergy, wheat allergy, celiac disease), Soy intolerance or allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume bread, tortillas, and arepas with varying percentages of soy flour to assess glycemic and insulin responses

1 day per product

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after consuming the products

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Soybean Flour

Trial Overview The study is testing the effect of substituting wheat flour with soybean flour on how quickly glucose is released into the bloodstream, which could potentially reduce hunger and lower the risk of diabetes.

How Is the Trial Designed?

Group I: Tortilla Experimental Treatment 1 Intervention

Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Group II: Bread Experimental Treatment 1 Intervention

Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Group III: Arepa Experimental Treatment 1 Intervention

Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Kenneth Dallmier Consulting, LLC

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Soy did not show a significant overall effect on weight, waist circumference, or fat mass, but certain conditions, such as in obese individuals or with higher soy protein intake, indicated a potential increase in weight.

In contrast, soy significantly reduced waist circumference in older adults and women, particularly at lower doses, while isoflavones showed a trend towards reducing body mass index (BMI) in women, especially at lower dosages and shorter intervention periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Soy and Soy Isoflavones on Obesity-Related Anthropometric Measures: A Systematic Review and Meta-analysis of Randomized Controlled Clinical Trials. Akhlaghi, M., Zare, M., Nouripour, F.[2023]

Soybean hull flour contains 37% more dietary fiber and higher iron content compared to hull-less soybean flour, making it a better nutritional choice.

The heat-treated soybean hull flour significantly improves iron bioavailability due to a lower phytate:iron ratio, leading to hemoglobin gains in rats comparable to a control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat-treated hull flour does not affect iron bioavailability in rats. Martino, HS., Carvalho, AW., Silva, CO., et al.[2023]

Roasting soybeans for 25 minutes (RSF25) significantly reduces antitryptic activity and immunoreactivity of proteins, improving their nutritional value without affecting essential amino acid levels.

In a study with growing rats, RSF25 flour led to less pancreatic hypertrophy compared to RSF15 flour, suggesting that longer roasting times can enhance the safety and nutritional quality of soybean protein in diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional value of the proteins of soybeans roasted at a small-scale unit level in Africa as assessed using growing rats. Ouédraogo, CL., Combe, E., Lallès, JP., et al.[2023]

This systematic review aims to evaluate the effectiveness of soy-based meal replacements for weight loss in overweight and obese individuals, focusing on primary outcomes like weight loss and secondary outcomes such as BMI and body fat.

By analyzing randomized controlled trials, the review seeks to provide strong evidence on how soy protein and isoflavones can aid in weight management, potentially offering a beneficial tool for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of soy-based meal replacement on weight loss: A systematic review and meta-analyses protocol. Heng, WK., Choo, JY., Ng, YP., et al.[2023]

Bread made with soy flour can provide a significant source of leucine, satisfying about one-fifth of the daily nutritional requirement for this important amino acid, which is crucial for muscle protein synthesis.

The combination of soy flour and preprocessed rice flour not only helps avoid gluten intolerance but also improves the bread's volume and palatability, making it a practical option for preventing muscle loss and improving nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Gluten-Free Soy Bread Quality and Amino Acid Content. Nakatani, T., Tanaka, M.[2023]

A study on weanling IIMb/Beta obese rats showed that diets containing 10% fiber from soybean hulls did not negatively impact growth, blood parameters, or fat depot weight, indicating safety for use in functional foods.

The positive effects observed in obese adult rats suggest that soybean hulls could be a beneficial ingredient for preventing and treating obesity in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of soy hulls as a potential ingredient of functional foods for the prevention of obesity. Olguin, MC., Posadas, MD., Revelant, GC., et al.[2023]

Supplementing wheat flour with 10% soy flour (both full fat and defatted) significantly improved the nutritional quality of bread, increasing protein content to 13.66% and 13.81%, compared to 11.47% in control wheat bread.

Defatted soy flour bread had a better shelf life than full fat soy flour bread, indicating that while both types enhance nutritional value, the defatted version is more suitable for longer storage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of supplementation on physicochemical, sensory and nutritional characteristics of bread. Dhingra, S., Jood, S.[2023]

A clinical trial involving eight older adults (ages 70-85) showed that consuming up to 30 g of processed whole green soybean flour per day was well-tolerated and helped participants feel full, suggesting potential benefits for weight management.

While the processing of soybean flour reduced its iron content, it also decreased oligosaccharides, which can cause flatulence, indicating that moderate consumption of soybean products may be safe and beneficial for older adults with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity. Rebello, CJ., Boué, S., Levy, RJ., et al.[2023]

In a 12-week study involving 100 obese participants, those using a low-calorie soy-based meal replacement lost significantly more weight (7.00 kg) compared to the control group (2.90 kg), indicating its efficacy for weight loss.

The meal replacement program also led to greater reductions in total cholesterol and LDL cholesterol levels, suggesting additional cardiovascular benefits beyond weight loss, and it was well tolerated with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. Allison, DB., Gadbury, G., Schwartz, LG., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5593113/

Effect of Soy and Soy Isoflavones on Obesity-Related ... In contrast to the effects of soy on weight, soy significantly decreased waist circumference in older ages (MD: −0.36 cm; 95% CI: −0.71, −0.01 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4170922/

The Effects of Soy Bean Flour Enriched Bread Intake on ... The results of our study showed no significant effects of soy bean flour enriched bread on anthropometric indices and blood pressure. Despite the slight ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900707001505

Effectiveness of a soy-based compared with a traditional ... It has been shown that a soy-based diet has a weight-loss effect and can prevent obesity because soy is rich in dietary fiber, thereby increasing satiety [7], ...

4. scirp.org scirp.org/journal/paperinformation?paperid=17532

Soy Consumption and Obesity Soy consumption seems to contribute approximately 10% - 21% to the worldwide variation in obesity, depending on the method of statistical analysis.

5. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/server/api/core/bitstreams/bd4c85a6-6aa5-4491-9d7f-21fecc67456c/content

A Dose-Escalating Clinical Trial in Older Adults with Obesity Processing soybean flour decreased the iron content, but reduced the oligosaccharides, which could attenuate flatulence. Providing soybean flour ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10141995/

Safety and Tolerability of Whole Soybean Products: A Dose ... We conducted a dose-escalating clinical trial of the safety and tolerability of soybean products in eight older adults (70–85 years) with obesity.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322008031

Effect of Soy and Soy Isoflavones on Obesity-Related ... We conducted this meta-analysis to evaluate potential effects of soy and soy isoflavones on weight, waist circumference, and fat mass.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1838825/

Role of Dietary Soy Protein in Obesity - PMC Soybeans and commercially available soy products contain approximately 0.1-5 mg isoflavones/g protein; one serving of traditional soy foods provides about 0.25- ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278691513006510

Soy in wheat – Contamination levels and food allergy risk ... Detectable levels of soy were found in 62.8% (22/35) of wheat flours during the market survey. All types of wheat flours contained detectable soy proteins.

10. researchgate.net researchgate.net/publication/370360473_Safety_and_Tolerability_of_Whole_Soybean_Products_A_Dose-Escalating_Clinical_Trial_in_Older_Adults_with_Obesity

A Dose-Escalating Clinical Trial in Older Adults with Obesity We conducted a dose-escalating clinical trial of the safety and tolerability of soybean products in eight older adults (70-85 years) with obesity.