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

The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Almond diet first, then NCEP Diet; Other: NCEP diet first, then Almond diet

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Almond diet first, then NCEP Diet; 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
Experimental: 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	Other: NCEP diet first, then Almond diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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
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
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
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
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
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 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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Jen-Fang Liu, PhD, Taipei Medical University

Publications and helpful links

General Publications

• Chen CM, Liu JF, Li SC, Huang CL, Hsirh AT, Weng SF, Chang ML, Li HT, Mohn E, Chen CO. Almonds ameliorate glycemic control in Chinese patients with better controlled type 2 diabetes: a randomized, crossover, controlled feeding trial. Nutr Metab (Lond). 2017 Aug 2;14:51. doi: 10.1186/s12986-017-0205-3. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: hyperglycemia; hyperinsulinemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PV0805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No