Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes But With Moderately Raised HbA1c
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in fasting and day long glucose levels
研究概览
简要总结
Higher than average blood sugar (glucose) levels are linked to an increased risk of developing type 2 diabetes. As such, there is interest in identifying dietary factors that could lower blood glucose to help reduce the number of people with this disease. Findings from some human studies indicate that dairy products, especially a milk protein (whey), may help the control of blood glucose levels. However, there is a need for further studies to confirm these findings in individuals without diabetes but with higher than average blood glucose levels.
详细描述
In the UK, more than 700 people are diagnosed with type 2 diabetes each day. Higher than average (raised) fasting blood sugar (glucose) is a characteristic of those at risk of developing this disease and as a result there is significant interest in dietary factors that could reduce levels of blood glucose, lowering the frequency of type 2 diabetes in the population. Existing scientific evidence suggests an important role of dairy products and especially of whey protein in the control of blood glucose levels. However, there is a need for further studies to confirm these findings in individuals without diabetes but with higher than average blood glucose levels.
Milk contains high quality proteins, of which 80% are caseins and 20% are whey proteins. Whey proteins are a rich source of branched-chain amino acids (such as leucine) which are thought to play an important role in regulating blood glucose control and other aspects of cardiovascular disease development in both healthy and type 2 diabetic subjects. However, very few studies in non-diabetic subjects with moderately raised HbA1c, characteristic of long-term poor glucose control, have been performed to investigate how whey protein affects blood glucose levels in the body especially when consumed over the longer term in the daily diet. Furthermore, data are limited on whether the leucine content of protein plays an important role in controlling blood glucose levels.
Study aims The main aims of this study is to investigate in adults without diabetes but with moderately raised HbA1c (a long- term marker of blood glucose control) whether a protein obtained from milk and dairy products (whey) has a beneficial effect on fasting and day-long blood glucose and insulin levels compared with a plant based protein (such as wheat). The researchers will also determine if leucine, a particular amino acid (building blocks of protein) found in higher levels in whey protein plays an important role in controlling blood glucose levels.
A secondary aim will determine whether the protein interventions influence risk markers for developing heart disease and diabetes including the level of blood lipids, hormones regulating blood sugar levels and blood vessel health.
This study will test the hypothesis that the incorporation of whey protein (total protein dose 50 g/d) in the habitual diet for 8 weeks will result in an improvement in fasting and day-long blood glucose and insulin levels, and other risk markers of heart disease and diabetes compared with wheat protein (total protein dose 50 g/d), and that the addition of leucine to wheat (to match the content found in whey protein) will improve blood glucose control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Coded protein products will be used.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20-35 kg/m2
- •HbA1c (5.7 - 6.5%) or (38.8 - 47.5 mmol/mol)
- •Fasting glucose 5.5-6.9 mmol/l
- •Fasting total cholesterol <7.5mmol/l
- •Fasting triacylglycerol <4.0 mmol/l
- •Not having a milk, gluten or wheat allergy or lactose intolerability
- •Not having diabetes (HbA1c < 47 mmol/mol) or < 6.5%
- •Not suffering from cardiovascular, renal, gastrointestinal, respiratory, endocrine or liver disease
- •Not having hypertension
- •Not diagnosed with cancer
- •Not having surgery in the previous 6 months
- •Not consuming more than the recommended intake of alcohol (>14 unit/wk)
- •Not being a blood donor 3 months prior to or during the study.
- •Not taking extra protein powder supplements in the previous 2 months
- •Not anaemic (Haemoglobin ≥115 g/l for women and ≥ 130 g/l for men)
- •Not taking medication for raised blood lipids, high blood pressure or for inflammatory conditions.
排除标准
- •Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
结局指标
主要结局
Change in fasting and day long glucose levels
时间窗: Before and after each 8 week intervention.
Blood glucose levels will be measured using a clinical chemistry analyser
Change in fasting and day long insulin levels
时间窗: Before and after each 8 week intervention.
Blood insulin levels will be measured using ELISA
次要结局
- Change in the total and HDL-cholesterol(Before and after each 8 week intervention)
- Change in fructosamine(Before and after each 8 week intervention)
- Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis(Before and after each 8 week intervention.)
- Change in non-esterified fatty acids(Before and after each 8 week intervention)
- Change in body composition(Before and after each 8 week intervention)
- Change in body weight(Before and after each 8 week intervention)
- Change in pulse wave analysis(Before and after each 8 week intervention)
- Change in insulin sensitivity(Before and after each 8 week intervention)
- Measurement of height(Before the start of the intervention)
- Change in body mass index(Before and after each 8 week intervention)
- Change in C-reactive protein(Before and after each 8 week intervention)
- Change in cellular adhesion molecule(Before and after each 8 week intervention)
- Change in beta-hydroxy butyrate(Before and after each 8 week intervention)
- Change in blood pressure(Before and after each 8 week intervention)
- Change in selectins(Before the start of the intervention)
研究者
Julie Lovegrove
Professor
University of Reading