The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Almond diet first, then NCEP Diet
NCEP diet first, then Almond diet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring hyperglycemia, hyperinsulinemia
Eligibility 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
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Almond diet first, then NCEP Diet
NCEP diet first, then Almond diet
Arm Description
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
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
Outcomes
Primary Outcome Measures
The Major Nutrients of NCEP Step 2 Diet and Almond Diets
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention
The Calories of NCEP Step 2 Diet and Almond Diets
Lipid Composition of NCEP Step 2 Diet and Almond Diets
Body Weight 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
Blood Pressure 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
Area Under Curve of Plasma Glucose After Eating Standard Breakfast 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
Area Under Curve of Plasma Insulin After Eating Standard Breakfast 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
HOMA at the Baseline and the End of 3-month Dietary Intervention
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention
Plasma Nitric Oxide Level 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
Plasma Protein Carbonyl Level 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
Urine Isoproterenol Level 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
Secondary Outcome Measures
Full Information
NCT ID
NCT01656850
First Posted
January 13, 2012
Last Updated
November 14, 2016
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01656850
Brief Title
The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
Official Title
The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
hyperglycemia, hyperinsulinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Almond diet first, then NCEP Diet
Arm Type
Experimental
Arm Description
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
Arm Title
NCEP diet first, then Almond diet
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Almond diet first, then NCEP Diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
NCEP diet first, then Almond diet
Intervention Description
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
Primary Outcome Measure Information:
Title
The Major Nutrients of NCEP Step 2 Diet and Almond Diets
Time Frame
the entire study, up to 3 months
Title
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
Title
The Calories of NCEP Step 2 Diet and Almond Diets
Time Frame
the entire study, up to 3 months
Title
Lipid Composition of NCEP Step 2 Diet and Almond Diets
Time Frame
the entire study, up to 3 months
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Fang Liu, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28785295
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
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