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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Soybean Flour for obesity?

Research suggests that soy-based meal replacements, which include soy protein and isoflavones, can help with weight loss and managing obesity. Additionally, soy products have been shown to decrease waist circumference, especially in women and older adults, which can be beneficial for obesity management. ^{1 2 3 4 5}

Is soy flour safe for human consumption?

Soy flour, used in various forms, has been generally well-tolerated in clinical trials, with no significant adverse effects reported. Some studies noted that soy products might cause mild gastrointestinal issues, but these were not severe. Overall, soy flour appears to be safe for human consumption. ^{1 2 3 4 5}

How does the treatment Soybean Flour differ from other treatments for obesity?

Soybean flour is unique because it is a natural, fiber-rich ingredient that can be used in functional foods to help prevent and treat obesity. Unlike many other treatments, it offers nutritional benefits such as high protein and amino acid content, which can support muscle health while addressing obesity. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Marta Y Pepino de Gruev, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of soy hulls as a potential ingredient of functional foods for the prevention of obesity. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity. [2023]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of soy-based meal replacement on weight loss: A systematic review and meta-analyses protocol. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing Gluten-Free Soy Bread Quality and Amino Acid Content. [2023]

7. Venezuela pubmed.ncbi.nlm.nih.gov

Heat-treated hull flour does not affect iron bioavailability in rats. [2023]

8. France 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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