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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jen-Fang Liu, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT01656850
First received: January 13, 2012
Last updated: February 16, 2016
Last verified: February 2016
  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: Almond diet first, then NCEP Diet
Other: NCEP diet first, then Almond diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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:


Further study details as provided by Taipei Medical University:

Primary Outcome Measures:
  • The Major Nutrients of NCEP Step 2 Diet and Almond Diets [ Time Frame: the entire study, up to 3 months ] [ Designated as safety issue: No ]
  • Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • The Calories of NCEP Step 2 Diet and Almond Diets [ Time Frame: the entire study, up to 3 months ] [ Designated as safety issue: No ]
  • Lipid Composition of NCEP Step 2 Diet and Almond Diets [ Time Frame: the entire study, up to 3 months ] [ Designated as safety issue: No ]
  • Body Weight at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • HOMA at the Baseline and the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]
  • Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention [ Time Frame: at the baseline and at the end of 3-month dietary intervention ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656850

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

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
Results First Received: October 19, 2015
Last Updated: February 16, 2016
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University:
hyperglycemia
hyperinsulinemia

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

ClinicalTrials.gov processed this record on May 26, 2016