Soy Flour for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Urbana-Champaign
Must not be taking: Diabetes medications
Disqualifiers: Smoking, Pregnancy, Diabetes, Hypertension, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12345How 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.
16789Eligibility 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
+1 more
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
+12 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: TortillaExperimental Treatment1 Intervention
Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
Group II: BreadExperimental Treatment1 Intervention
Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
Group III: ArepaExperimental Treatment1 Intervention
Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at Urbana ChampaignChampaign, IL
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Who Is Running the Clinical Trial?
University of Illinois at Urbana-ChampaignLead Sponsor
Kenneth Dallmier Consulting, LLCCollaborator
References
Evaluation of soy hulls as a potential ingredient of functional foods for the prevention of obesity. [2023]The prevalence of obesity and its associated health problems is rising to epidemic proportions throughout the world. Soy hulls, an industrial waste from oil extraction, contain a high proportion of fiber--soluble and insoluble--and may be a potential ingredient of functional foods for the prevention of obesity. However, crude soybeans, as do all legumes, present challenges to their use because of intensive antitrypsin and antichimotrypsin activity that impairs normal growth in humans and other mammals, requiring inactivation. To evaluate possible antinutritional effects of soybean hulls, diets with 10 percent fiber from soybean hulls or cellulose were offered to weanling IIMb/Beta obese rats during their prepubertal timeframe. The fact that no significant differences were found in growth, blood parameters nor in fat depots' weight and lipid content plus the proven beneficial effects on obese adult rats suggest that soy hulls may be a useful ingredient of functional foods for the prevention and treatment of human obesity.
Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity. [2023]Soybean products have nutrients, dietary fiber, and phytoalexins beneficial for cardiovascular and overall health. Despite their high consumption in Asian populations, their safety in Western diets is debated. We conducted a dose-escalating clinical trial of the safety and tolerability of soybean products in eight older adults (70-85 years) with obesity. Whole green soybean pods grown under controlled conditions were processed to flour (WGS) at the United States Department of Agriculture using common cooking techniques such as slicing and heat treatment. WGS incorporated into food products was consumed at 10 g, 20 g, and 30 g/day for one week at each dose. The gastrointestinal outcomes, clinical biomarkers, and adverse events were evaluated. We explored the stimulation of phytoalexin (glyceollin) production in live viable soybean seeds (LSS-G). We compared the compositions of WGS and LSS-G with commercial soybean flour and its fermented and enzymatically hydrolyzed forms. We found that although 30 g WSG was well-tolerated, and it made participants feel full. Our processing produced glyceollins (267 µg/g) in LSS-G. Processing soybean flour decreased the iron content, but reduced the oligosaccharides, which could attenuate flatulence. Providing soybean flour at
Effect of Soy and Soy Isoflavones on Obesity-Related Anthropometric Measures: A Systematic Review and Meta-analysis of Randomized Controlled Clinical Trials. [2023]Soy may be a suitable food for anti-obesity efforts because of its high protein and isoflavone content. We conducted this meta-analysis to evaluate potential effects of soy and soy isoflavones on weight, waist circumference, and fat mass. PubMed, MEDLINE, Scopus, EMBASE, and Cochrane databases were searched. Twenty-four trials with soy and 17 trials with isoflavones passed the eligibility stage. According to the results, soy showed no overall statistically significant effect on weight, waist circumference, or fat mass, but a significant increasing effect on weight was observed in some circumstances: for instance, in obese subjects [mean difference (MD): 0.80 kg; 95% CI: 0.15, 1.45 kg; P = 0.02], with ingestions of ≥40 g soy protein/d (MD: 0.94 kg; 95% CI: 0.11, 1.77 kg; P = 0.03), with short-term applications (1-3 mo) (MD: 0.45 kg; 95% CI: 0.05, 0.86 kg; P = 0.03), and when soy was compared with meat (MD: 0.36 kg; 95% CI: 0.09, 0.64 kg; P = 0.03) and whey protein (MD: 1.53 kg; 95% CI: 0.10, 2.96 kg; P = 0.04). 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 cm; P = 0.04), in women (MD: -0.32 cm; 95% CI: -0.57, -0.08 cm; P = 0.01), and at doses of <40 g soy protein/d (MD: -0.31 cm; 95% CI: -0.57, -0.05 cm; P = 0.02). Isoflavone studies, conducted only in women, showed that isoflavones may reduce body mass index (BMI; in kg/m2) (MD: -0.26; 95% CI: -0.55, 0.04; P = 0.085), especially in dosages <100 mg/d (MD: -0.48; 95% CI: -0.90, -0.06; P = 0.02) and in intervention periods of 2-6 mo (MD: -0.28; 95% CI: -0.56, 0.00; P = 0.053), but no effect was observed in higher doses or longer intervention periods. Also, a trend for reduced BMI after consumption of isoflavones was observed in Caucasians (MD: -0.35; 95% CI: -0.74, 0.04; P = 0.08). Overall, results showed that, although soy is the major source of isoflavones, soy and isoflavones may have different impacts on weight status.
A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. [2023]To assess the efficacy and safety of a low calorie soy-based meal replacement program for the treatment of obesity.
Effect of soy-based meal replacement on weight loss: A systematic review and meta-analyses protocol. [2023]Background: Obesity is a complex and multifactorial disease that is strongly associated with multiple comorbidities and mortality. Weight reduction in overweight and obese patients was highly desired to minimize future complications. Meal replacement is emerging as one of the effective tools to promote weight loss. Isoflavones and soy protein present in soybean are able to promote weight loss and alleviate obesity. Aim: Our systematic review aims to investigate the weight loss effect of soy-based meal replacement among the overweight and obese population. Methods: We will conduct a systematic review of RCTs that evaluated the effect of a soy-based meal replacement on weight loss in overweight and obese patients. The primary outcome of this review is weight loss. Besides that, we will assess BMI, body fat, waist circumference and hip circumference as the secondary outcome. We will search PubMed and the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library. Two reviewers will independently screen titles and abstracts, review full texts, extract information and assess the risk of bias of individual studies. We will conduct meta-analyses using a random-effect model if sufficient data are available. If meta-analysis is not performed, we will present a systematic qualitative synthesis. Summary: This systematic review will identify the weight loss effect of soy-based meal replacement among the overweight and obese adult population. We expect the result may strengthen the evidence on the role of soy-based meal replacement in optimal body weight management.
Assessing Gluten-Free Soy Bread Quality and Amino Acid Content. [2023]The nutritional and palatability relevance of bread prepared with soy flour was examined. There are a few effective nutritional measures that combine palatability, convenience, and functionality in the suppression of muscle loss (contributing to the improvement and prevention of sarcopenia). Therefore, in the present study, we attempted to produce bread using soybeans, which are rich in amino acids involved in the synthesis and degradation of skeletal muscle proteins. Rice flour was also used to avoid gluten intolerance. The bread was baked in an automatic bread maker, and the rheological properties of its breadcrumbs were determined using a creep meter. We found that a 70 g slice of soy bread satisfied approximately one-fifth of the daily nutritional requirement for leucine. Although soy decreased the specific volume of bread by preventing starch construction, the use of preprocessed rice flour recovered the volume, and corn starch improved the taste. We propose that the addition of soy bread to the daily diet may be an effective protein source.
Heat-treated hull flour does not affect iron bioavailability in rats. [2023]In this study the chemical composition and iron bioavailability of hull and hull-less soybean flour from the new cultivar UFVTN 105AP was evaluated. The hemoglobin depletion-repletion method was used in Wistar rats. Soybean hull flour presented 37% more total dietary fiber and higher content of iron than hull-less soybean flour. The phytate:iron molar ratio, however, was 2-fold lower in the soybean hull flour in compared to the hull-less soybean flour. Animals fed soybean hull flour presented hemoglobin gains similar to those of the control diet group (p > 0.05). The Relative Biological Values of hull and hull-less soybean flour were 68.5% and 67.1%, respectively, compared to the control group. Heat-treated soybean hull flour (150 degrees C/30 minutes) showed high content of iron and low phytate, which favors the iron bioavailability. Thus, the soybean hull flour is a better source of dietary fiber and iron than hull-less soybean flour at comparable bioavailabilities.
Nutritional value of the proteins of soybeans roasted at a small-scale unit level in Africa as assessed using growing rats. [2023]Increasing the roasting time of soybeans from 15 (RSF15) to 25 (RSF25) min led to an important decrease in the antitryptic activity and immunoreactivity of the storage globulins, but it did not seem to greatly affect the concentrations of the indispensable amino acids in the protein. The RSF15 and RSF25 flours were used as the only protein sources in balanced diets for growing rats, and they were compared to a diet based on casein in a pair-feeding experiment. When roasted as usually happens at the workshop level (RSF15), soybean flour induced a significant hypertrophy of the pancreas. Increasing the roasting time by up to 25 min considerably improved the nutritional value of the soybean protein, without apparent consequence on the levels of free amino acid pools in the plasma and muscles. The data also indicated that the tissues of the small and large intestines of the young rat were sensitive to the hyperactivity of the intestinal microflora, and also possibly to the residual activity of some antinutritional factors.
Effect of supplementation on physicochemical, sensory and nutritional characteristics of bread. [2023]Supplementation of wheat flour with soy flour (full fat and defatted) at 5, 10, 15 and 20% levels was carried out to test the effect on physico-chemical, sensory, nutritional evaluation and shelf life of breads. Adding 10% of soy flour (full fat and defatted) produced breads with good baking and organoleptic characteristics. However, at 15 and 20% levels they were less acceptable. The better breads were further investigated for various nutritional parameters and shelf life. Full fat and defatted soy flour (10%) supplemented bread exhibited 13.66 and 13.81% protein, and 3.02 and 3.05 g/100 g protein total lysine contents as compared to control (wheat) bread (11.47% protein and 2.36 g/100 g protein total lysine). Other nutrients are also increased in supplemented breads as compared to wheat bread. However, for storage, defatted soy supplemented bread exhibited better shelf life than the full fat version.