The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Almond diet first, then NCEP Diet; NCEP diet first, then Almond diet
Intervention type(s): Other; Other
Intervention description(s): whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. Subjects were assigned to receive almond diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to NCEP Diet for 12 weeks; NCEP diet first, then Almond diet. Subjects were assigned to receive NCEP diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to almond diet for 12 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperglycemia; hyperinsulinemia