N/A
N=40
The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01656850 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: The Major Nutrients of NCEP Step 2 Diet and Almond Diets — 17.5; 17.2; 38.4; 29.2 % of energy — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Almond diet first, then NCEP Diet (Other); NCEP diet first, then Almond diet (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Taipei Medical University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Major Nutrients of NCEP Step 2 Diet and Almond Diets |
17.5; 17.2; 38.4; 29.2; 47.0; 55.7 | <0.0001 sig |
| PRIMARY Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention |
44.8; 49.7; 45.2; 48.5; 97.5; 102.9 | 0.2786 |
| PRIMARY The Calories of NCEP Step 2 Diet and Almond Diets |
1,665.9; 1,643.4 | 0.420 |
| PRIMARY Lipid Composition of NCEP Step 2 Diet and Almond Diets |
22.0; 22.3; 30.7; 12.7; 11.1; 9.5 | <0.0001 sig |
| PRIMARY Body Weight at the Baseline and at the End of 3-month Dietary Intervention |
64.7; 64.8; 65.3; 64.7 | 0.2412 |
| PRIMARY Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention |
31.6; 31.4; 31.0; 31.7 | 0.3837 |
| PRIMARY Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention |
124.2; 123.6; 124.5; 122.1; 74.9; 77.3 | 0.9784 |
| PRIMARY Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention |
146.5; 139.6; 140.7; 140.3 | 0.5868 |
| PRIMARY Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention |
37424; 36415; 35768; 37706 | 0.1101 |
| PRIMARY Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention |
11.2; 12.3; 10.4; 11.8 | 0.7823 |
| PRIMARY Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention |
3975; 4690; 4055; 4345 | 0.5570 |
| PRIMARY Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention |
7.47; 7.45; 7.51; 7.39 | 0.6263 |
| PRIMARY HOMA at the Baseline and the End of 3-month Dietary Intervention |
4.00; 4.24; 3.58; 3.98 | 0.8328 |
| PRIMARY Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention |
128.9; 135.1; 128.3; 135.3; 82.9; 85.8 | 0.7758 |
| PRIMARY Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention |
59.6; 72.1; 62.5; 50.6 | 0.0476 sig |
| PRIMARY Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention |
43.4; 44.0; 46.1; 42.3; 22.3; 22.9 | 0.1205 |
| PRIMARY Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention |
1.00; 1.06; 1.00; 0.72 | 0.1512 |
| PRIMARY Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention |
32.8; 34.8; 33.9; 35.1 | 0.7364 |
| PRIMARY Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention |
12.2; 14.2; 11.9; 12.2 | 0.1995 |
| PRIMARY Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention |
8.51; 9.24; 8.86; 9.57 | 0.8528 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01656850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.