Effect of cashew nut supplementation on glycemic status and lipid profile in type 2 diabetic subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To assess changes in glycemic, and lipid profile among type 2 diabetic subjects by daily supplementation of cashew nuts in their diets
研究概览
简要总结
There is a rapid increase in the prevalence of type 2 diabetes worldwideand the morbidity and mortality associated with the disease is a major concernespecially in the developing countries like India. Primary intervention through diet and lifestyle modificationassumes paramount importance in the prevention and management of diabetes.Studies have shown that reduction in the incidence of diabetes can be achievedover long period through modest dietary changes, weight loss and exercise. With increasing awareness on the effect of refined grains onpostprandial hyperglycemia and reduction in HDL cholesterol, replacementof carbohydrate by healthy fat, such as monounsaturated fatty acids (MUFAs) andpolyunsaturated fatty acids (PUFAs), has been increasingly recognized as apossible therapeutic strategy in the treatment of diabetes.
Nutsare energy dense foods and the unique nutrient composition of nuts may confer metabolic benefits and reduce therisk of developing coronary heart disease (CHD) and diabetes. Independentclinical studies have shown multiple beneficial effects of nut consumption suchas weight loss, reduced inflammation and cardiovascular disease risk.Higher nut consumption is associated with a reduced risk of diabetes and of thedevelopment of coronary heart disease in individuals with diabetes.Cross sectional studies have shown decreased levels ofsoluble inflammatory markers and increase in serum adiponection concentrationupon nut consumption. Cashew nuts are one of the commonly consumed nuts in the Indianpopulation. Various studies have demonstrated the beneficial properties ofcashew nuts in animal models. A recent clinical study have shown twoounces of nuts daily as a replacement for carbohydrate foods improved bothglycemic control and serum lipids in type 2 diabetes. Not many studies havebeen done on the health benefits of nuts specifically in the diabetic subjectsin the Indian population. The aim ofthis study will be to look at the effect of cashew nut consumption on theglycemic and lipid profile in the chosen type 2 diabetic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Type 2 diabetic subjects Only with oral hypoglycemic agents [OHA] ie., metformin, Gliptins and / or sulphonylureas, HbA1c between 7.0 -11.0 % Willing to follow study protocol Willing to give informed consent.
排除标准
- •1.Subjects with known allergy to cashew nuts 2.Subjects on statins 3.Subjects on insulin 4.LDL cholesterol > 190 mg/dl 5.Total serum cholesterol >240 mg/dl 6.Serum Triglycerides > 300 mg/dl 7.Any acute infections 8.Chronic diseases such as tuberculosis, disorders of liver, kidney, heart, lungs and other organs etc.
- •9.Pregnant and lactating Women.
结局指标
主要结局
To assess changes in glycemic, and lipid profile among type 2 diabetic subjects by daily supplementation of cashew nuts in their diets
时间窗: 3 months
次要结局
- 2.To evaluate the effects of daily cashew nut supplementation on anthropometric measurements and clinical indicators of general health(3 months)
