The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Energy expenditure
研究概览
简要总结
Wheat and wheat derived products are highly consumed around the world. They constitute the major dietary source of protein and energy for many individuals. Wheat contains moderate quantity of low quality protein lacking in some essential amino acids, primarily lysine, thus wheat based diets can't sustain optimal growth, and accordingly should be supplemented with lysine or complemented by another protein source of better quality to match human needs. However, human studies showed that wheat flour fortification with lysine was able to slightly improve growth, namely by increasing weight gain, but it did not however completely reverse growth impairment provoked by the consumption of wheat-based diets.
The investigators developed interest in the role of phosphorus in health and diseased and believe that the modest impact of lysine fortification may due to low phosphorus availability of wheat products. Phosphorus content of cereals is mainly in the form of phytate that is not bioavailable. Supplementing a wheat gluten based diet with a combination of lysine and phosphorus was able to highly amplify the increase in weight gain and energy efficiency of rats as compared to lysine or phosphorus supplementation alone. Phosphorus is an essential mineral known to be directly involved in the production of ATP, which is essential for many metabolic processes including protein synthesis.
The investigators believe that a better approach to enhance the quality of a wheat-based diet is through the supplementation with a combination of both lysine and phosphorus.
The present study is designed to investigate the effect of white flour fortification with lysine and/or phosphorus on sensory properties, postprandial glycaemia and insulinemia, as well as postprandial thermogenesis.
Most specifically, we aim to:
- Determine the acceptability and assess sensory differences of the fortified breads.
- Determine the glycemic response after ingestion of the different fortified breads.
- Evaluate the variation in energy expenditure after the consumption of the fortified breads.
详细描述
Specific Aim 1: Determine the acceptability and assess sensory differences of the fortified breads.
White wheat flour will be fortified with either lysine, phosphorus, or both lysine and phosphorus. The acceptability of these fortified breads will be tested.
L- Lysine monohydrochloride will be used as the sources of lysine. Potassium phosphate will be used as the source of phosphorus. From previous experience, the addition of potassium phosphate to glucose solution was found to minimally affect the organoleptic properties. Unlike that of sodium phosphate that was not well tolerated by subjects due to development of unfavorable flavor (fishy flavor).
Locally produced white wheat flour (80% extraction) will be purchased and stored at the department. White flour samples will be analyzed for their content of phosphorus according to standard procedures.
Fortification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Efforts will be made to age and gender match subjects (balanced number of males and females in each group). Subjects are appropriate if they are in the age range between 18 and
- •Women who are in the reproductive age will be studied at the first half of their menstrual cycle, because estrogen is known to affect the energy expenditure. Postmenopausal women taking hormonal replacement therapy will be excluded. Subjects should have: Cr <1mg/dl for women and <1.2mg/dl for men and GFR >60 ml/min/1.73m2.
排除标准
- •Subjects with diabetes, cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrinological (PTH), or any significant medical disease will be excluded.
- •Pregnant and lactating women.
- •Subjects on regular use of medication that affects body weight and/or having a weight loss of 3% or more in the preceding 3 months.
- •Subjects with: Cr >1mg/dl for women and >1.2mg/dl for men and GFR<60 ml/min/1.73m2.
结局指标
主要结局
Energy expenditure
时间窗: 240 min
Postprandial energy expenditure
Postprandial glycemia
时间窗: 120 min
postprandial blood glucose level
次要结局
未报告次要终点
研究者
Omar Obeid
professor
American University of Beirut Medical Center