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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond diet first, then NCEP Diet | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond diet first, then NCEP Diet | Other | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jen-Fang Liu, PhD | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28785295 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Whole Almonds First, Then NCEP Diet | run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months) |
| FG001 | NCEP Diet First, Then Whole Almonds Diet | run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Months) |
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| Washout (2 Weeks) |
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| Second Intervention (3 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Almond Diet First, Then NCEP Diet | whole almonds to replace 20% daily calorie intake 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. |
| BG001 | NCEP Diet First, Then Almond Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Posted | Mean | Standard Deviation | % of energy | the entire study, up to 3 months |
|
|
one week for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Almond Diet | participants received experiment diet containing 20% calorie from whole almond |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liu, Jen-Fang | Taipei Medical University | +886-3-2118999 | 5487 | liujenfa@mail.cgust.edu.tw |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D006946 | Hyperinsulinism |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| NCEP diet first, then Almond diet | Other | 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 |
|
| 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 |
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| NOT COMPLETED |
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follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mg/dL | at the baseline and at the end of 3-month dietary intervention |
|
|
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|
| Primary | The Calories of NCEP Step 2 Diet and Almond Diets | Posted | Mean | Standard Deviation | kcal | the entire study, up to 3 months |
|
|
|
|
| Primary | Lipid Composition of NCEP Step 2 Diet and Almond Diets | Posted | Mean | Standard Deviation | g | the entire study, up to 3 months |
|
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|
|
| Primary | Body Weight at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | kg | at the baseline and at the end of 3-month dietary intervention |
|
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|
|
| Primary | Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | percentage of body weight | at the baseline and at the end of 3-month dietary intervention |
|
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| Primary | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mmHg | at the baseline and at the end of 3-month dietary intervention |
|
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|
|
| Primary | Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mg/dL | at the baseline and at the end of 3-month dietary intervention |
|
|
|
|
| Primary | Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mg.min/dL | at the baseline and at the end of 3-month dietary intervention |
|
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|
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| Primary | Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mU/L | at the baseline and at the end of 3-month dietary intervention |
|
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|
|
| Primary | Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | mU.min/L | at the baseline and at the end of 3-month dietary intervention |
|
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| Primary | Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | percentage of hemoglubin | at the baseline and at the end of 3-month dietary intervention |
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| Primary | HOMA at the Baseline and the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | pg/mL | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | g/L | at the baseline and at the end of 3-month dietary intervention |
|
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| Primary | Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | μmol/L | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | ng/mL | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | nmol/mg | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | U/L | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | ng/mg creatinine | at the baseline and at the end of 3-month dietary intervention |
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| Primary | Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | Posted | Mean | Standard Deviation | μmol/L | at the baseline and at the end of 3-month dietary intervention |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | NCEP Diet | participants received NCEP diet for 3 months | 0 | 33 | 0 | 33 |
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| D004700 | Endocrine System Diseases |
| LDL |
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| Total cholesterol |
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| Triglyceride |
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| SFA |
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| DBP |
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| Apo B |
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| ICAM-1 |
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