Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. Preliminary clinical data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite. Its use may therefore have potential implications in long-term weight management, while improving diabetes.
The objective of this research (weight loss) is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. Participants were randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat bran control supplement matched for energy. The effect of the supplements on weight-loss (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels) will be assessed. In addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and prothrombin time) and satiety scores were evaluated.
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite. In light of the high incidence of obesity in individuals with diabetes, Salba grain may be a useful addition to the diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Well-controlled type 2 diabetes for at least 1 year
- •Treated with diet and/or oral hypoglycemic medications
- •BMI 25-40 kg/m2
排除标准
- •Weight change in the past three months >10% of body weight
- •On insulin therapy
- •Unstable angina, myocardial infarction or stroke (within 6 months)
- •Planned surgery or pregnancy
- •Blood pressure >160mmHg/100mmHg
- •Surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite
- •ALA, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week
结局指标
主要结局
Weight
时间窗: 24 weeks
24 week timeframe for Weightloss phase
次要结局
- Body composition(24 weeks)
- Low grade body inflammation(24 weeks)
- Satiety hormones(24 weeks)
- serum ALT(24 weeks)
- serum creatinine(24 weeks)
- Blood urea(24 weeks)
- Fatty Acids (% composition)(24 weeks)
- Blood sugar control(24 weeks)
- Prothrombin time(24 weeks)