The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Other: Almond diet first, then NCEP Diet
Other: NCEP diet first, then Almond diet

Registration Number: NCT01656850

Lead Sponsor: Taipei Medical University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

aged between 40-70 years,
with BMI = 24-35 kg/m2,
HbA1c 6.5-9 %, and
regular use of oral hypoglycemic agents.

Exclusion Criteria

Use of insulin to control blood glucose
Regular use of oral steroids
Regular use of anti-inflammatory agents (prescribed [Rx] or over-the-counter [OTC])
Gain or loss of larger than 5% of body weight in the last 6 months
CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia
Gastrointestinal: diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease, inflammatory bowel disease, treatment with acid-lowering drugs
Renal: chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis, diabetic nephropathy, serum creatinine > 1.5 mg/dL
Endocrine: disease, untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease, hyperuricemia
Rheumatologic: gout, inflammatory arthritis
Active treatment for cancer of any type (except basal cell carcinoma) 1 year
Systolic blood pressure larger than 150 mmHg, and diastolic blood pressure larger than 95 mmHg.
Any history of or known allergies to nuts of any kind
Frequent nut consumption, defined as ≥ 3 oz/wk; however, subjects who are willing to refrain from eating all nuts and nut products for 6 wk prior to their initial visit (Visit 1) may be considered eligible
Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 1) and throughout the entire study may be considered eligible
Usual daily ethanol intake of larger or equal to 2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
Illicit drug use
Specific laboratory blood or urine analysis parameters of: creatinine larger than 1.5 mg/dL, ALT and AST larger than 1.5 nmol/L, and urinalysis - hematuria and proteinuria

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Almond diet first, then NCEP Diet	Almond diet first, then NCEP Diet	In a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period
NCEP diet first, then Almond diet	NCEP diet first, then Almond diet	In a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period

Primary Outcome Measures

Name	Time	Method
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
The Major Nutrients of NCEP Step 2 Diet and Almond Diets	the entire study, up to 3 months
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
The Calories of NCEP Step 2 Diet and Almond Diets	the entire study, up to 3 months
Lipid Composition of NCEP Step 2 Diet and Almond Diets	the entire study, up to 3 months
Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Body Weight at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
HOMA at the Baseline and the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention
Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention	at the baseline and at the end of 3-month dietary intervention