The aim of this study is to investigate the effect of Cashew Consumption on lipid profile, Apo B, Apo A-I, hs-CRP, and Paraoxonase-1 in type 2 diabetic patients. In this parallel group, randomized controlled trial, 50 men and women with type 2 diabetes aged 35-70 years old will be recruited from Iranian Diabetes Society. The study will be explained to each participant to sign informed consent. Prior to the study, the subjects will be required to complete 3-days 24-hour dietary recall. Diets will be analyzed for calorie and macronutrients content. Then, we will substitute 10% of usual daily calorie intake with Cashew in intervention group. The control group will follow their habitual diet. Blood samples will be obtained after an overnight fasting before and after the study. All anthropometric and physical activity variables will be measured both before and after the trial. Diets and medications dosage will be held constant throughout the study and each subject’s exercise level will be kept constant and monitored by physical activity questionnaires (IPAQ).Compliance will be assessed from 3-days 24-recalls which obtain at first, in the middle and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812252709N5
Registration date:2010-03-16, 1388/12/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-03-16, 1388/12/25
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cashew consumption on lipid profile, Apo B, Apo A-I, hs-CRP and Paraoxonase-1 in patients with type 2 diabetes.
Public title
Effect of Cashew consumption on lipid profile in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being volunteer or willingness to attend, age 35-70 years old, confirmed type 2 diabetes for at least 1 year (FPG ≥ 126 mg/dl or 2hPG ≥ 200 mg/dl), BMI ≤ 35 kg/m2, TG < 400 mg/dl, HbA1C < 9%, LDL ≤ 200 mg/dl, Blood pressure ≤160/90 mmHg
Exclusion criteria: Allergy to nuts, insulin consumption, Smoking cigarette, drinking alcohol or drug abuse, Diabetic nephropathy or retinopathy, History of stroke or heart attack, Thyroid disease, Following vegetarian or weight-reducing diets 2 months prior to the study, Eating nuts > 2 times/wk at least 2 months prior to the study, Changing medication dosage or physical activity level 2 months before or during the study
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Islamic & Complementary Medicine