Know Cancer

or
forgot password

Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes


Phase 2
21 Years
N/A
Open (Enrolling)
Both
Type 2 Diabetes, Cardiovascular Disease, Diet Therapy

Thank you

Trial Information

Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes


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 diets:(1) Full-Dose Nut Diet: Raw nuts will be added as supplements to the
subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by
Lipid Research Clinic (LRC) tables, will receive the full-dose supplement (100 g/d of nuts,
approximately 600 kcal). Subjects requiring between 1,600-2,400 kcal daily will receive 75%
of the full-dose supplement (75 g/d of nuts, approximately 450 kcal). Subjects requiring
less than 1,600 kcal daily will receive 50% of the full-dose supplement (50 g/d of nuts,
approximately 300 kcal). (2) Half-Dose Nut Diet: Raw nuts will be added as supplements to
the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by
LRC tables, will receive half of the full dose of the nut supplement (50 g/d 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 1,600-2,400 kcal daily will
receive 75% of the half-dose supplement (37.5 g/d of nuts and 1.5 muffins, approximately 450
kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the half-dose
supplement (25 g/d 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, i.e. either 600 kcal/d (4 muffins); 450 kcal/d (3
muffins); 300 kcal/d (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.

Palatability/Satiety: 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.


Inclusion Criteria:



- Men and post menopausal women with type 2 diabetes treated with diet plus oral
hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin),
Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for
at least 3 months prior to starting the study;

- HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and
the level which is currently considered unacceptable.

- Diabetes diagnosed >6 months prior to randomization

- Weight stable within 3% body weight >2 months.

Exclusion Criteria:

- Use of acarbose

- Use of Insulin

- Known nut allergies

- Clinically significant gastroparesis

- Use of steroids

- Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)

- Major cardiovascular event (stroke or myocardial infarction)

- Major surgery < 6 months prior to randomization

- Presence of major debilitating disorder such as clinically significant liver disease
(not including non-alcoholic fatty liver (NAFL) or non-alcoholic steatohepatitis
(NASH) but including cirrhosis, infectious hepatitis (B and C), aspartate
transaminase (AST) or alanine transaminase (ALT) > 130 IU/L)

- Renal failure (high creatinine > 150 mmol/L)

- Serum triglyceride > 6 mmol/L.

- Patients currently undergoing treatment for cancer with the exception of non-melanoma
skin cancer, but not high risk patients or those whose treatment has been
successfully completed.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Markers of glycemic control: Fasting serum fructosamine

Outcome Time Frame:

From prestudy and week 0, to end of treatment weeks 8, 10, 12

Safety Issue:

Yes

Principal Investigator

David JA Jenkins, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Toronto, St. Michael's Hospital

Authority:

Canada: Health Canada

Study ID:

REB 06-274

NCT ID:

NCT00410722

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Type 2 Diabetes
  • Cardiovascular Disease
  • Diet Therapy
  • Nutrition
  • Type 2 Diabetes
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

Name

Location