Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410722
Status:
UNKNOWN
Last Update Posted:
2013-01-09
First Post:
2006-12-12
Brief Title:
Effect of Nuts vs a Wheat Bran Muffin in Type 2 Diabetes
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if tree nuts Almonds Hazelnuts Pistachios Peanuts Macadamia nuts Pecans Walnuts and Cashews improve glycemic control in type 2 diabetes as assessed by HbA1c and serum fructosamine and to assess whether these outcomes relate to improvements in cardiovascular health ie plasma lipids and measures of oxidative stress inflammatory biomarkers and nitric oxide generation The investigators have found that nuts tend to reduce the glycemic index of bread and have little effect of raising blood glucose on their own Therefore the investigators believe that they would be ideal foods to displace high glycemic foods from the diet and lower the dietary glycemic load This will result in improved blood glucose control in type 2 diabetes with additional benefits on coronary heart disease risk factors due to other effects of nuts
Detailed Description:
The investigators wish to study the effect of nuts on glycemic control and to confirm their lipid lowering effects in type 2 diabetes The consumption of nuts with their high unsaturated fat vegetable protein arginine and fiber contents will decrease the glycemic load of the diet and improve glycemic control The investigators anticipate that the favorable fatty acid profile of nuts along with the vegetable protein will improve the blood lipid profile in type 2 diabetes and thereby establish a cardiovascular risk reduction associated with nuts in this population
Furthermore flavonoids and vitamin E present in high concentrations in nuts and known to have antioxidant activity may help to counter the elevated oxidative stress and inflammation experienced by diabetics The investigators will therefore determine the effect of nut feeding on measures of oxidative stress including oxidized low-density lipoprotein cholesterol LDL-C considered to be of direct relevance to coronary heart disease inflammation C-reactive protein serum amyloid A and interleukin-6 and nitric oxide metabolism blood nitric oxide and nitrotyrosine levels These data would further add to interest in nuts in relation to cardiovascular disease risk reduction and diabetic complications
Background Diet A diet conforming to the American Diabetes Association ADA and National Cholesterol Education Program NCEP Adult Treatment Panel III guidelines Nuts soy and dietary supplements vitamins minerals herbal remedies will be excluded in the background diet during all phases of the study
Treatment diets1 Full-Dose Nut Diet Raw nuts will be added as supplements to the subjects usual diet Subjects with calorie needs of 2400 kcal or greater assessed by Lipid Research Clinic LRC tables will receive the full-dose supplement 100 gd of nuts approximately 600 kcal Subjects requiring between 1600-2400 kcal daily will receive 75 of the full-dose supplement 75 gd of nuts approximately 450 kcal Subjects requiring less than 1600 kcal daily will receive 50 of the full-dose supplement 50 gd of nuts approximately 300 kcal 2 Half-Dose Nut Diet Raw nuts will be added as supplements to the subjects usual diet Subjects with calorie needs of 2400 kcal or greater assessed by LRC tables will receive half of the full dose of the nut supplement 50 gd of nuts approximately 300 kcal with the rest of the calories provided by the muffin 2 muffins are 300 kcal for a total of 600 kcal Subjects requiring between 1600-2400 kcal daily will receive 75 of the half-dose supplement 375 gd of nuts and 15 muffins approximately 450 kcal Subjects requiring less than 1600 kcal daily will receive 50 of the half-dose supplement 25 gd of nuts and 1 muffin approximately 300 kcal 3 The full-dose control supplement will be four 150 kcal muffins Control supplements will be matched with the energy content of the nut supplements ie either 600 kcald 4 muffins 450 kcald 3 muffins 300 kcald 2 muffins The macronutrient composition of the muffins will conform to an NCEP Step 2 diet with 25 total fat 7 saturated fat by use of corn oil as the oil commonly used in healthy baked goods with 18 protein the average for our subject population using added skim milk powder and zero cholesterol Muffins will be made with whole wheat flour
Diet History one-week weighed diet histories will be obtained prior to the start and at weeks 4 8 and 12 of the study for assessment of macronutrients dietary fiber and fatty acids
PalatabilitySatiety for palatability and satiety subjects will record their ratings using a 7-point bipolar semantic scale at monthly intervals during each study phase
Anthropometry and Blood Pressure height at recruitment and body weight blood pressure waist and hip circumference and body composition will be taken immediately prior to and at each clinic visit wk 0 2 4 8 10 12 during the study
Furthermore flavonoids and vitamin E present in high concentrations in nuts and known to have antioxidant activity may help to counter the elevated oxidative stress and inflammation experienced by diabetics The investigators will therefore determine the effect of nut feeding on measures of oxidative stress including oxidized low-density lipoprotein cholesterol LDL-C considered to be of direct relevance to coronary heart disease inflammation C-reactive protein serum amyloid A and interleukin-6 and nitric oxide metabolism blood nitric oxide and nitrotyrosine levels These data would further add to interest in nuts in relation to cardiovascular disease risk reduction and diabetic complications
Background Diet A diet conforming to the American Diabetes Association ADA and National Cholesterol Education Program NCEP Adult Treatment Panel III guidelines Nuts soy and dietary supplements vitamins minerals herbal remedies will be excluded in the background diet during all phases of the study
Treatment diets1 Full-Dose Nut Diet Raw nuts will be added as supplements to the subjects usual diet Subjects with calorie needs of 2400 kcal or greater assessed by Lipid Research Clinic LRC tables will receive the full-dose supplement 100 gd of nuts approximately 600 kcal Subjects requiring between 1600-2400 kcal daily will receive 75 of the full-dose supplement 75 gd of nuts approximately 450 kcal Subjects requiring less than 1600 kcal daily will receive 50 of the full-dose supplement 50 gd of nuts approximately 300 kcal 2 Half-Dose Nut Diet Raw nuts will be added as supplements to the subjects usual diet Subjects with calorie needs of 2400 kcal or greater assessed by LRC tables will receive half of the full dose of the nut supplement 50 gd of nuts approximately 300 kcal with the rest of the calories provided by the muffin 2 muffins are 300 kcal for a total of 600 kcal Subjects requiring between 1600-2400 kcal daily will receive 75 of the half-dose supplement 375 gd of nuts and 15 muffins approximately 450 kcal Subjects requiring less than 1600 kcal daily will receive 50 of the half-dose supplement 25 gd of nuts and 1 muffin approximately 300 kcal 3 The full-dose control supplement will be four 150 kcal muffins Control supplements will be matched with the energy content of the nut supplements ie either 600 kcald 4 muffins 450 kcald 3 muffins 300 kcald 2 muffins The macronutrient composition of the muffins will conform to an NCEP Step 2 diet with 25 total fat 7 saturated fat by use of corn oil as the oil commonly used in healthy baked goods with 18 protein the average for our subject population using added skim milk powder and zero cholesterol Muffins will be made with whole wheat flour
Diet History one-week weighed diet histories will be obtained prior to the start and at weeks 4 8 and 12 of the study for assessment of macronutrients dietary fiber and fatty acids
PalatabilitySatiety for palatability and satiety subjects will record their ratings using a 7-point bipolar semantic scale at monthly intervals during each study phase
Anthropometry and Blood Pressure height at recruitment and body weight blood pressure waist and hip circumference and body composition will be taken immediately prior to and at each clinic visit wk 0 2 4 8 10 12 during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None