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

This study is currently recruiting participants.
Verified July 2012 by Taipei Medical University
Sponsor:
Information provided by (Responsible Party):
Jen-Fang Liu, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT01656850
First received: January 13, 2012
Last updated: August 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Other: whole almonds
Other: NCEP Step 2 diet

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Medical University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be diagnosed with diabetes larger than 5 years,
  • aged between 40-70 years,
  • with BMI = 24-35 kg/m2,
  • serum cholesterol larger than 200 mg/dL,
  • HbA1c 6.5-9 %, and
  • regular use of oral hypoglycemic agents.

Exclusion Criteria:

  • Use of medications known to affect lipid metabolism, i.e., hypolipidemic or cholesterol-lowering agents
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656850

Contacts
Contact: Jennifer Wu, MS 011-886-220153183 goues2000@yahoo.com.tw

Locations
Taiwan
Taipei Medical University Recruiting
Taipei City, Taiwan
Principal Investigator: Jen-Fang Liu, PhD            
Sponsors and Collaborators
Taipei Medical University
Investigators
Principal Investigator: Jen-Fang Liu, PhD Taipei Medical University
  More Information

No publications provided

Responsible Party: Jen-Fang Liu, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01656850     History of Changes
Other Study ID Numbers: PV0805
Study First Received: January 13, 2012
Last Updated: August 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University:
hyperglycemia
hyperinsulinemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013