Effect of Cashew Nut Supplementation on Body Weight, Glycemic and Lipid Profile in Asian Indian Adults with Type 2 Diabetes

Active, not recruiting

Conditions: Type 2 diabetic patients

Registration Number: CTRI/2017/07/009022

Lead Sponsor: Madras Diabetes Research Foundation

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess changes in glycemic, and lipid profile among type 2 diabetic subjects by daily supplementation of cashew nuts in their diets	3 months

Secondary Outcome Measures

Name	Time	Method
2.To evaluate the effects of daily cashew nut supplementation on anthropometric measurements and clinical indicators of general health	3 months

Trial Locations

Locations (1): Department of Foods Nutrition and Dietetics Research,Madras Diabetes Research Foundation
🇮🇳
Chennai, TAMIL NADU, India
Department of Foods Nutrition and Dietetics Research,Madras Diabetes Research Foundation
🇮🇳Chennai, TAMIL NADU, India
Dr V Mohan
Principal investigator
drmohans@diabetes.ind.in