The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
Recruitment status was Recruiting
The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes|
- Change in HbA1c [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]The change in HbA1c values between the baseline and at the end of dietary intervention serves as the primary outcome.
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Whole almonds
whole almonds to replace 20% daily calorie intake
Other: whole almonds
Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.
|Placebo Comparator: NCEP step 2 diet||Other: NCEP Step 2 diet|
Our previous study demonstrated almonds (~60 g/d) improved lipid profile, glucoregulation, inflammation, and oxidative stress in 20 Chinese patients with type 2 diabetes mellitus (T2DM). To follow-up and expand this work with a more robust trial, the investigators propose a larger (n = 40), longer-term (90-d) investigation of the effect of almonds (~60 g/d) on adipokine regulation, endothelial function, glucoregulation, inflammation, lipid profile, and oxidative stress in Chinese patients with T2DM as compared to a placebo control. The investigators will conduct a 7-mo randomized, cross-over, placebo controlled clinical trial in which all meals will be provided to all subjects (n = 40). During the first 2 weeks (run-in period), all subjects will receive a control diet resembling a typical Taiwan diet, prepared based on the NCEP Step 2 guidelines. During the following 3 mo (Phase I), subjects will be randomized to receive either the control diet or the control diet with whole almonds (~60g/d) incorporated to replace 20% calories. After a 2-wk washout period during which all subjects will once again receive the control diet, subjects will receive the opposite diet to the one assigned during the Phase I for the other 3 months (Phase II). The caloric content of each diet will be adjusted to each subjects' energy needs to prevent any change in body weight. The following biomarkers will be determined at the baseline and end of each dietary intervention: Glucoregulation: fasted serum HbA1c, glucose and insulin, postprandial serum glucose and insulin, and urinary C-peptide; Endothelial Function: brachial artery FMD and serum nitric oxide, e-selectin, endothelial-1 (ET-1), and intracellular adhesion molecule-1 (ICAM-1); Adipokine Regulation: serum adiponectin, leptin, and resistin; Inflammation: serum high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, retinol binding protein-4 (RBP-4), and tumor necrosis factor (TNF)-α; Oxidative Stress: urinary isoprostanes (adjusted for creatinine) and serum protein carbonyls and oxidized LDL; and Lipid Profile: serum cholesterol, triglycerides, and apolipoproteins A1 and B.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656850
|Contact: Jennifer Wu, MSfirstname.lastname@example.org|
|Taipei Medical University||Recruiting|
|Taipei City, Taiwan|
|Principal Investigator: Jen-Fang Liu, PhD|
|Principal Investigator:||Jen-Fang Liu, PhD||Taipei Medical University|