The Effect of the Inclusion of Soybean Flour on Glycemic Responses of Bread, Tortilla, and Arepa to Enhance Human Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Plasma glucose
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Bread
Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
干预措施: Replacement of wheat flour by soyflour (Other)
Tortilla
Bread will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
干预措施: Replacement of wheat flour by soyflour (Other)
Arepa
Arepa will be prepared with 100 % of wheat flour and with some replacements by different % of soy flour (at three concentrations)
干预措施: Replacement of wheat flour by soyflour (Other)
结局指标
主要结局
Plasma glucose
时间窗: -30 minutes to 120 min post-prandially
Concentrations of glucose in plasma before and at different times post-prandially
Plasma insulin
时间窗: -30 minutes to 120 min post-prandially
Concentrations of insulin in plasma before and at different times post-prandially
次要结局
- Hunger-Satiety(Before and after (10-180 min) they consume the different food products (bread, arepa, tortillas))