The present study evaluated the changes in emerging cardiac biomarkers, cognitive function, and social support measures after a comprehensive lifestyle intervention that included a low-fat, whole-foods, plant-based diet, exercise, stress management, and group support meetings. We conducted a prospective cohort study of 131 participants (59.2% women and 43.1% with diabetes mellitus), 56 with coronary heart disease (CHD) (37.5% women and 27.3% diabetes mellitus), and 75 at high risk with ≥3 CHD risk factors and/or diabetes mellitus (76% women and 54.7% diabetes mellitus). The measurements were taken at baseline and 3 months after the intervention. Improvement in all targeted health behaviors was seen in both high-risk and CHD groups (all p <0.001) at 3 months, with reductions in body mass index, systolic and diastolic blood pressure, waist/hip ratio, C-reactive protein, insulin, low-density lipoprotein, high-density and total cholesterol, apolipoproteins A1 and B (all p <0.009) were observed. Nuclear magnetic resonance spectroscopy analysis of lipoprotein subclass particle concentrations and diameters showed a reduction in large very-low-density lipoprotein particles, size of the very-low-density lipoprotein particles, total low-density lipoprotein particles; total, large, and small high-density lipoprotein particles (all p <0.009) and small very-low-density lipoprotein particles (p <0.02). Increases in fibrinogen (p <0.03) and B-type natriuretic peptide (p <0.001) were seen, and these changes correlated inversely with the changes in the body mass index. The observed increase in B-type natriuretic peptide can be explained by the metabolic changes related to adipose tissue lipolysis. The quality of life, cognitive functioning, and social support measures significantly improved. In conclusion, lifestyle changes can be followed by favorable changes in traditional and emerging coronary heart disease biomarkers, quality of life, social support, and cognitive function among those with, or at high risk, of CHD.
Comprehensive lifestyle changes have previously been studied in randomized controlled trials and prospective cohort studies and have been shown to cause a reduction in traditional risk factors of coronary heart disease (CHD) and in symptoms and signs of established CHD. To examine the possible mechanisms underlying these beneficial effects, the present study assessed the changes in emerging biomarkers that are potential risk factors for, or risk markers of, CHD, traditional risk factors for CHD, quality of life, cognitive function, and social support after a comprehensive lifestyle intervention of 3 months’ duration among those at risk of, or with pre-existing, CHD.
Methods
A prospective cohort study nested within a larger cohort participating in the health insurance-administered Multisite Cardiac Lifestyle Intervention Program was conducted. The participating hospital sites included the Charleston Area Medical Center, West Virginia, Hamot Medical Center, Pennsylvania, Jameson Health System, Pennsylvania, Jefferson Regional Medical Center, Pennsylvania, and West Virginia University Hospitals, West Virginia. The institutional review board at each site approved the study, and each participant provided written informed consent before enrollment. The present study was registered at Clinicaltrials.gov (identifier NCT00820313 ).
Details on the eligibility criteria for the Multisite Cardiac Lifestyle Intervention Program and the lifestyle intervention have been previously published.
In brief, the patients were eligible if they had been diagnosed with CHD or with type 1 or type 2 diabetes mellitus or were at high risk of CHD. The diagnosis of CHD was by 1 of the following criteria: (1) noninvasive testing, including exercise testing, nuclear imaging, echocardiography, or other tests demonstrating ischemia; (2) cardiac catheterization; (3) eligibility for bypass surgery/percutaneous transluminal coronary angioplasty and seeking a clinical alternative, or (4) a history of coronary artery bypass surgery, percutaneous transluminal coronary angioplasty/stent placement, or myocardial infarction. The criteria for high-risk status were (1) a family history of premature CHD (first-degree relative [men aged <55 years, women aged <65 years] with myocardial infarction or sudden cardiac death) or men aged >45 years or women aged >55 years; and (2) had ≥2 of the following: (a) current cigarette smoking (within the past 5 years), (b) hypertension (blood pressure >140/90 mm Hg or taking antihypertensive agents), (c) low high-density lipoprotein (HDL) cholesterol <35 mg/dl or taking lipid-lowering medications, (d) elevated lipoprotein (a) >30 mg/dl, (e) total cholesterol >240 mg/dl or taking lipid-lowering medications, (f) low-density lipoprotein (LDL) cholesterol >160 mg/dl or taking lipid-lowering medications, (g) high-sensitivity C-reactive protein of 3 to 10 mg/L, (h) body mass index (BMI) >30 kg/m 2 , or (i) insulin-resistant state (metabolic syndrome X).
The primary exclusion criteria included (1) left main obstruction >50% in diameter; (2) >70% proximal left anterior descending artery disease, proximal left circumflex artery disease, and an ejection fraction of <50%; (3) unstable angina pectoris; (4) a history of exercise-induced ventricular tachycardia or third-degree heart block without evidence of current stability; (5) coronary artery bypass graft surgery or myocardial infarction within 4 weeks; (6) heart failure with functional limitations and unresponsiveness to medications; (7) current tobacco user; (8) uncontrolled malignant ventricular arrhythmia; and (9) impaired cognitive function, such as dementia or delirium.
The dietary guidelines prescribed included approximately 10% of daily calories from fat, 15% from protein, and 75% from complex carbohydrates. The participants were asked to perform a minimum of 3 hours each week of aerobic exercise and to spend a minimum of 30 minutes per session exercising within their prescribed target heart rates and/or perceived exertion levels, to perform strength training activities a minimum of 2 times each week, and to practice stress management techniques for at least 1 hour each day. In addition, they attended weekly group support sessions held twice each week by a licensed mental health professional.
The demographic information and medical history were obtained at baseline by interview and a review of medical records. The clinical measurements, blood test results, and questionnaires were collected at baseline and at 3 months. The clinical measurements included height, weight, abdominal circumference, hip circumference, and blood pressure at rest, which was measured according to the American Heart Association practice guidelines. Functional capacity was assessed using maximum treadmill or bicycle ergometry testing. A fasting blood sample was drawn for laboratory analyses, including total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, high-sensitivity C-reactive protein, fibrinogen, lipoprotein (a), homocysteine, oxidized LDL, insulin, B-type natriuretic peptide (BNP), and nuclear magnetic resonance Lipoprofile assays (Quest Diagnostics Clinical Trials, Valencia, California) for LDL, very-low-density lipoprotein (VLDL), and HDL particle concentrations and particle size. In addition, the fasting blood glucose and hemoglobin A1c were assessed for participants with diabetes mellitus. Self-administered questionnaires were completed by participants to assess the exercise and stress management duration and frequency per week, quality of life, perceived stress, depression, hostility, social support, and cognitive function. In addition, 3-day food diaries were completed by the participants. These were entered into the software program Food Processor, version 10.x (Esha Research, Salem, OR) by registered dieticians for nutrient analysis. We included only those nutrients for statistical analysis for which ≥90% of the food items had reported values in the Esha nutrient database used by the Food Processor program.
Statistical analysis was conducted using the Statistical Package for Social Sciences, version 14.0 (SPSS, Chicago, Illinois). A diet adherence score and a lifestyle adherence score were calculated using the same formula as previously described. Higher scores indicated better adherence to the recommendations. Continuous data are presented as the mean ± standard deviation for normally distributed variables and as the median and interquartile range or range for non-normally distributed variables. Differences between groups for these variables were tested for significance using t tests and Mann-Whitney rank sum tests, and changes from baseline were tested for significance using paired t tests and the Wilcoxon signed ranks test. Cardiac biomarker distributions were not normal, and log-transformed values were used for parametric tests. The association between the continuous variables was evaluated using linear regression analysis. Pearson’s r and associated 2-sided p values were computed for bivariate correlations.
Results
The baseline characteristics are listed in Table 1 . We evaluated the correlations of the baseline cognitive function scores with the lifestyle variables at baseline and found significant inverse correlations with the baseline percentage of calories from fat (n = 128, r = −0.242, p = 0.006). The correlations with exercise and stress management scores were not significant.
| Characteristic | Diagnosed With CHD (n = 54) | High Risk of CHD (n = 71) | ||
|---|---|---|---|---|
| Men (n = 35) ⁎ | Women (n = 19) ⁎ | Men (n = 16) ⁎ | Women (n = 55) ⁎ | |
| Age (years) | 58.2 ± 7.6 | 59.9 ± 7.0 | 57.3 ± 7.8 | 56.1 ± 9.8 |
| Ethnicity (white) | 32/35 (91%) | 19/19 (100%) | 15/16 (94%) | 51/55 (93%) |
| Previous cigarette smoker | 15/35 (43%) | 5/19 (26%) | 8/16 (50%) | 19/55 (35%) |
| Diabetes mellitus | 8/35 (23%) | 7/19 (37%) | 10/16 (63%) | 29/55 (53%) |
| Previous myocardial infarction | 15/35 (43%) | 7/19 (37%) | NA | NA |
| Previous percutaneous coronary intervention | 19/35 (54%) | 11/19 (55%) | NA | NA |
| Previous coronary bypass | 10/35 (29%) | 4/19 (21%) | NA | NA |
| Medications | ||||
| Nitrates | 3/35 (9%) | 1/19 (5%) | 0/16 (0%) | 0/55 (0%) |
| Lipid lowering | 32/35 (91%) | 16/19 (84%) | 9/16 (56%) | 20/55 (36%) |
| Weight (lb) | 216 ± 46 | 184 ± 36 | 243 ± 49 | 209 ± 43 |
| Waist (in.) | 43.1 ± 5.8 | 40.9 ± 8.0 | 47.9 ± 6.2 | 43.3 ± 6.3 |
| Waist/hip ratio | 1.00 ± 0.06 | 0.91 ± 0.10 | 1.05 ± 0.07 | 0.91 ± 0.07 |
| Body mass index (kg/m 2 ) | 32.1 ± 6.2 | 32.7 ± 6.6 | 36.6 ± 6.8 | 35.6 ± 7.1 |
| Systolic blood pressure (mm Hg) | 127 ± 17 | 126 ± 14 | 134 ± 16 | 127 ± 13 |
| Diastolic blood pressure (mm Hg) | 77 ± 8 | 74 ± 8 | 80 ± 14 | 77 ± 8 |
| Angina frequency † ‡ (times/week) | ||||
| Median | 0.0 | 0.0 | NA | NA |
| Range | 0.0–5.0 | 0.0–2.0 | ||
| Angina severity † ‡ | ||||
| Median | 0.0 | 0.0 | NA | NA |
| Range | 0.0–2.0 | 0.0–1.0 | ||
| Functional capacity (METS) | ||||
| Median | 8.8 | 5.4 | 7.6 | 7.5 |
| Interquartile range | 5.9–11.6 | 3.6–10.1 | 6.3–9.1 | 6.2–10.0 |
| Dietary fat (g) | ||||
| Median | 52 | 49 | 78 | 58 |
| Interquartile range | 33–71 | 33–86 | 45–135 | 35–74 |
| Dietary cholesterol (mg) | ||||
| Median | 145 | 127 | 276 | 155 |
| Interquartile range | 74–201 | 83–219 | 170–446 | 95–270 |
| Exercise (minutes/week) | ||||
| Median | 80 | 0 | 0 | 0 |
| Interquartile range | 0–200 | 0–120 | 0–52 | 0–112 |
| Stress management (minutes/week) † | ||||
| Median | 0.0 | 0.0 | 0.0 | 0.0 |
| Interquartile range | 0.0–0.0 | 0.0–0.0 | 0.0–0.0 | 0.0–0.0 |
| Depression § | ||||
| Median | 8.0 | 12.0 | 8.5 | 9.0 |
| Interquartile range | 5.0–16.0 | 4.3–20.5 | 2.0–16.0 | 5.0–14.0 |
| Hostility § (Cook-Medley scale) | ||||
| Median | 8.0 | 4.5 | 8.0 | 5.0 |
| Interquartile range | 4.0–12.0 | 2.3–9.8 | 5.5–10.5 | 3.0–8.0 |
| Physical component score § | ||||
| Median | 47.1 | 46.0 | 47.8 | 47.6 |
| Interquartile range | 38.9–54.7 | 33.6–50.1 | 42.2–52.4 | 39.6–52.6 |
| Mental component score § | ||||
| Median | 52.9 | 48.3 | 53.7 | 51.8 |
| Interquartile range | 42.6–57.8 | 36.9–57.0 | 34.7–59.9 | 40.0–56.8 |
⁎ Because of missing data, number of patients for specific variables ranges from 30 to 35 for men with CHD, 16 to 19 for women with CHD, 13 to 16 for men at high risk of CHD, and 44 to 55 for women at high risk of CHD.
† Full range reported owing to low baseline values.
‡ Angina frequency, 0 (least frequent angina symptoms) to 6 (most frequent angina symptoms); angina severity, 0 (least severe) to 4 (most severe).
§ Depression (Centers for Epidemiologic Studies–Depression scale): 0 (least depressed) to 60 (most depressed); hostility: 0 (least hostile) to 40 (most hostile); physical and mental component scores (Medical Outcomes Study 36-item short-form survey): 0 (lowest physical/mental health) to 100 (highest physical/mental health).
At 3 months, significant changes in diet with a reduction in calories, protein, fat, saturated fat, cholesterol, and sodium intake and an increase in carbohydrates, fiber, vitamin A, vitamin C, calcium, and iron were observed ( Table 2 ). Exercise and stress management practices had increased significantly at 3 months, and group support meeting attendance was high with a mean attendance of 97% ( Table 2 ). Health-related quality of life, cognitive function scores, and social support measures improved from baseline, and a significant reduction in depression, hostility, and perceived stress scores was seen ( Table 3 ).
| Variable | Total (n = 125 ⁎ ) | CHD (n = 54 ⁎ ) | High risk (n = 71 ⁎ ) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 3 mo | p Value | Baseline | 3 mo | p Value | Baseline | 3 mo | p Value | |
| Total energy (kcal) | 1,738 (1,470–2,198) | 1,399 (1,191–1,672) | <0.001 | 1,769 (1,484–2,229) | 1,422 (1,222–1,743) | <0.001 | 1,722 (1,447–2,132) | 1,393 (1,166–1,622) | <0.001 |
| Protein (g) | 75 (60–88) | 61 (53–73) | <0.001 | 75 (60–85) | 61 (55–72) | 0.002 | 78 (60–91) | 63 (53–75) | 0.003 |
| Carbohydrates (g) | 240 (189–310) | 254 (219–308) | 0.006 | 261 (212–319) | 256 (222–329) | 0.51 | 228 (185–281) | 253 (213–297) | 0.001 |
| Dietary fiber (g) | 22.1 (14.5–30.2) | 34.1 (28.9–41.6) | <0.001 | 26.6 (15.7–31.8) | 34.1 (26.7–41.5) | <0.001 | 20.1 (14.0–27.8) | 34.1 (29.3–41.9) | <0.001 |
| Fat intake (% calories) | 525 (308–712) | 152 (124–182) | <0.001 | 475 (298–661) | 160 (130–195) | <0.001 | 546 (326–765) | 145 (122–177) | <0.001 |
| Saturated fat (g) | 17.4 (8.5–26.3) | 2.1 (1.7–2.9) | <0.001 | 16.5 (6.7–24.8) | 2.2 (1.8–3.0) | <0.001 | 18.9 (11.5–28.6) | 2.1 (1.6–2.8) | <0.001 |
| Cholesterol (mg) | 152.3 (90.9–251.0) | 7.2 (3.7–11.0) | <0.001 | 141.4 (76.9–202.4) | 6.5 (2.9–12.4) | <0.001 | 176.6 (111.9–281.2) | 8.0 (4.8–10.9) | <0.001 |
| Vitamin A (IU) | 6,276 (4,085–8,314) | 8,419 (6,068–12,019) | <0.001 | 5,802 (4,159–7,720) | 8,067 (6,048–11,056) | 0.002 | 6,602 (4,028–9,398) | 8,466 (6,066–12,291) | 0.01 |
| Vitamin C (mg) | 74 (45–126) | 116 (81–169) | <0.001 | 72 (51–119) | 117 (79–188) | 0.002 | 79 (41–133) | 114 (81–159) | <0.001 |
| Calcium (mg) | 731 (536–993) | 927 (719–1,166) | <0.001 | 747 (523–973) | 869 (651–1,088) | 0.124 | 684 (542–1,088) | 996 (747–1,196) | <0.001 |
| Iron (mg) | 13.6 (10.6–20.6) | 20.0 (15.2–27.3) | <0.001 | 13.6 (10.6–23.4) | 18.5 (14.7–27.4) | 0.002 | 14.0 (11.1–20.0) | 20.6 (15.9–27.3) | <0.001 |
| Sodium (mg) | 2,822 (2,206–3,906) | 2,327 (1,853–3,009) | <0.001 | 2,667 (2,153–4,101) | 2,284 (1,762–3,105) | 0.024 | 2,838 (2,318–3,898) | 2,424 (1,925–2,814) | 0.001 |
| Exercise (min/week) | 0.0 (0.0–115.0) | 212.0 (180.0–275.0) | <0.001 | 60.0 (0.0–185.0) | 205.0 (178.0–280.0) | <0.001 | 0.0 (0.0–90.0) | 221.5 (180.0–278.8) | <0.001 |
| Stress management (min/week) † | 0.0 (0.0–0.0) | 420.0 (355.0–425.0) | <0.001 | 0.0 (0.0–0.0) | 380.0 (338.5–420.0) | <0.001 | 0.0 (0.0–0.0) | 420.0 (376.3–444.8) | <0.001 |
| Body mass index (kg/m 2 ) | 33.6 (6.9) | 31.8 (6.2) | <0.001 | 32.3 (6.3) | 30.2 (5.9) | <0.001 | 34.2 (6.9) | 32.9 (6.3) | <0.001 |
| Waist/hip ratio | 1.0 ± 0.1 | 0.9 ± 0.1 | <0.001 | 1.0 ± 0.1 | 0.9 ± 0.1 | <0.001 | 0.9 ± 0.1 | 0.9 ± 0.1 | <0.001 |
| Systolic blood pressure (mm Hg) | 128 ± 15 | 117 ± 11 | <0.001 | 127 ± 16 | 115 ± 10 | <0.001 | 128 ± 15 | 118 ± 12 | <0.001 |
| Diastolic blood pressure (mm Hg) | 77 ± 8 | 72 ± 7 | <0.001 | 76 ± 8 | 70 ± 7 | <0.001 | 77 ± 8 | 73 ± 6 | <0.001 |
| Functional capacity (METS) | 7.6 (5.6–10.1) | 10.1 (7.8–12.5) | <0.001 | 7.9 (4.5–10.3) | 10.8 (7.2–13.5) | <0.001 | 7.6 (5.6–10.1) | 10.1 (7.9–11.7) | <0.001 |
⁎ Because of missing data, numbers of patients for individual variables ranged from 118 to 123.
† Full range reported for baseline owing to low baseline values.
| Variable | Total (n = 125 ⁎ ) | CHD (n = 54 ⁎ ) | High risk (n = 71 ⁎ ) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 3 mo | p Value | Baseline | 3 mo | p Value | Baseline | 3 mo | p Value | |
| Health-related quality of life † | |||||||||
| Physical functioning | 80 (55–90) | 90 (80–95) | <0.001 | 75 (50–90) | 90 (75–100) | <0.001 | 80 (60–90) | 90 (80–95) | <0.001 |
| Bodily pain | 62 (51–84) | 84 (62–84) | <0.001 | 62 (48–84) | 74 (57–84) | 0.034 | 72 (51–84) | 84 (62–88) | <0.001 |
| General health | 62 (42–77) | 77 (67–87) | <0.001 | 62 (45–77) | 77 (62–87) | <0.001 | 57 (41–72) | 82 (67–87) | <0.001 |
| Vitality | 51 (32–68) | 77 (62–85) | <0.001 | 51 (34–69) | 74 (62–84) | <0.001 | 50 (31–68) | 78 (60–87) | <0.001 |
| Social functioning | 88 (63–100) | 100 (88–100) | <0.001 | 88 (50–100) | 100 (88–100) | 0.002 | 88 (75–100) | 100 (88–100) | <0.001 |
| Mental health | 76 (64–88) | 88 (80–92) | <0.001 | 72 (60–88) | 88 (80–92) | <0.001 | 76 (64–88) | 88 (76–92) | <0.001 |
| Physical component score | 47 (39–52) | 52 (46–56) | <0.001 | 46 (36–53) | 51 (43–56) | 0.001 | 47 (39–52) | 53 (49–56) | <0.001 |
| Mental component score | 52 (40–57) | 57 (53–59) | <0.001 | 51 (40–57) | 56 (53–59) | <0.001 | 52 (40–56) | 57 (53–59) | <0.001 |
| Seeman and Syme Social Support Scale | |||||||||
| Instrumental social support ‡ (0–9) | 3.0 (2.0–4.0) | 3.0 (2.0–4.0) | 0.20 | 2.0 (1.0–4.0) | 2.0 (2.0–4.0) | 0.09 | 3.0 (2.0–4.0) | 3.0 (2.0–4.0) | 0.09 |
| Emotional social support ‡ (0–9) | 5.0 (3.0–6.0) | 6.0 (3.0–7.0) | 0.006 | 4.0 (3.0–6.3) | 5.0 (3.0–7.0) | 0.07 | 5.0 (3.0–6.3) | 6.0 (4.0–7.0) | 0.035 |
| Total social support ‡ (0–3) | 1.2 (0.8–1.7) | 1.3 (1.0–1.8) | 0.015 | 1.3 (0.7–1.7) | 1.3 (0.8–1.7) | 0.224 | 1.2 (0.8–1.7) | 1.5 (1.0–1.8) | 0.028 |
| Network adequacy ‡ (0–4) | 2.8 (2.5–3.1) | 3.0 (2.5–3.3) | 0.001 | 2.9 (2.5–3.3) | 3.0 (2.7–3.3) | 0.084 | 2.8 (2.3–3.0) | 3.0 (2.5–3.3) | 0.007 |
| Other | |||||||||
| Depression ‡ § (0–60) | 9.0 (5.0–15.0) | 4.0 (2.0–8.0) | <0.001 | 9.0 (5.0–17.0) | 5.0 (2.0–8.5) | <0.001 | 8.0 (4.0–14.0) | 4.0 (1.0–8.0) | <0.001 |
| Hostility ‡ ¶ (0–27) | 7.0 (3.0–10.0) | 5.0 (2.0–9.0) | <0.001 | 7.5 (4.0–11.0) | 6.0 (3.0–9.0) | 0.014 | 6.0 (3.0–10.0) | 4.0 (2.0–9.0) | 0.004 |
| Perceived stress ‡ (0–40) | 13.0 (9.0–19.0) | 8.0 (5.0–14.0) | <0.001 | 13.0 (8.8–19.0) | 8.0 (6.0–14.5) | <0.001 | 13.0 (9.0–19.0) | 7.0 (5.0–12.5) | <0.001 |
| Cognitive functioning scale ‡ ∥ (0–100) | 83 (70–93) | 90 (80–96) | <0.001 | 80 (66–93) | 85 (75–93) | 0.11 | 83 (73–93) | 90 (83–96) | <0.001 |
⁎ Because of missing data, numbers of patients for specific variables ranged from 121 to 123.
† Medical Outcomes Study 36-Item Short-Form Health Survey.
‡ Health-related quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey): 0 (lowest quality of life) to 100 (greatest quality of life); instrumental social support: 0 (lowest amount of support) to 9 (highest amount of support); emotional social support: 0 (lowest amount of support) to 9 (greatest amount of support); total social support: 0 (lowest amount of support) to 3 (greatest amount of support); network adequacy: 1 (least adequate) to 4 (most adequate); depression: 0 (least depressed) to 60 (most depressed); hostility: 0 (least hostile) to 27 (most hostile); perceived stress: 0 (least perceived stress) to 40 (most perceived stress); cognitive functioning: 0 (lowest cognitive functioning) to 100 (greatest cognitive functioning).
§ Center for Epidemiological Studies depression scale.
¶ Cook-Medley hostility scale.
∥ Cognitive Functioning subscale of Medical Outcomes Survey 36-item short form.
Traditional cardiac risk factors, including BMI, total cholesterol, and LDL cholesterol showed statistically significant decreases from baseline in both the CHD and high-risk groups, as did C-reactive protein and insulin. Apolipoprotein A1 and apolipoprotein B levels decreased significantly in both groups, and the change in the apolipoprotein B/apolipoprotein A1 ratio was not significant. Among patients with diabetes mellitus, the fasting blood glucose and hemoglobin A1c levels had decreased significantly in both CHD and high-risk groups ( Table 4 ). A reduction in the total particle numbers for VLDL, intermediate-density lipoprotein, LDL, and HDL was observed, with statistically significant reductions in the total LDL and total HDL particles ( Table 5 ). The VLDL particle size decreased significantly, and the proportion of large and small VLDL particles decreased and the proportion of medium VLDL particles increased from a median of 41% to 47% (p <0.003). The distribution of HDL size subclasses did not change significantly nor did the distribution of LDL size subclasses, except for a reduction in the intermediate-density lipoprotein particle proportion from a median of 4% to 3% (p <0.04; Tables 5 and 6 ). Overall, the changes from baseline to 3 months of follow-up were in the same direction in both the CHD and the high-risk groups ( Tables 2 to 6 ).
| Variable | Total (n = 125 ⁎ ) | CHD (n = 54 ⁎ ) | High risk (n = 71 ⁎ ) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 3 mo | p Value † | Baseline | 3 mo | p Value † | Baseline | 3 mo | p Value † | |
| Biomarkers of lipid metabolism | |||||||||
| Total cholesterol (mg/dl) | 180 (153–205) | 161 (143–198) | <0.001 | 165 (136–190) | 143 (109–174) | <0.001 | 185 (164–224) | 176 (147–198) | <0.001 |
| Low-density lipoprotein cholesterol (mg/dl) | 103 (78–124) | 81 (64–112) | <0.001 | 89 (68–109) | 68 (49–100) | <0.001 | 109 (88–133) | 104 (72–117) | <0.001 |
| High-density lipoprotein cholesterol (mg/dl) | 44.0 (37.0–50.0) | 37.5 (33.0–44.3) | <0.001 | 42.0 (35.8–50.0) | 37.0 (32.0–44.5) | <0.001 | 44.5 (38.5–50.0) | 38.0 (33.5–43.5) | <0.001 |
| Triglycerides (mg/dl) | 129 (95–185) | 125 (80–176) | 0.07 | 113 (80–162) | 113 (65–174) | 0.8 | 135 (100–212) | 142 (89–187) | 0.035 |
| Very-low-density lipoprotein triglycerides (mg/dl) | 92 (58–150) | 93 (48–145) | 0.22 | 89 (49–126) | 81 (41–138) | 0.96 | 102 (63–170) | 104 (53–155) | 0.11 |
| Lipoprotein (a) (nmol/L) | 30.0 (6.0–133.5) | 30.0 (6.0–132.3) | 0.41 | 48.0 (15.5–163.5) | 56.5 (13.3–185.8) | 0.7 | 18.5 (6.0–67.3) | 56.5 (13.3–185.8) | 0.17 |
| Oxidized low-density lipoprotein (U/L) | 59 (46–81) | 57 (43–78) | 0.07 | 54 (41–80) | 50 (35–63) | 0.17 | 54 (41–80) | 61 (47–83) | 0.25 |
| Apolipoprotein A1 (mg/dl) | 139 (124–156) | 124 (110–138) | <0.001 | 133 (117–148) | 118 (107–134) | 0.002 | 147 (131–162) | 127 (115–140) | <0.001 |
| Apolipoprotein B (mg/dl) | 87 (69–109) | 84 (65–99) | 0.001 | 78 (66–97) | 82 (54–93) | 0.09 | 94 (82–112) | 87 (71–106) | 0.002 |
| Apolipoprotein B/apolipoprotein A1 | 0.6 (0.5–0.8) | 0.7 (0.5–0.8) | 0.064 | 0.6 (0.5–0.8) | 0.5 (0.6–0.8) | 0.30 | 0.7 (0.6–0.8) | 0.7 (0.6–0.8) | 0.114 |
| Other biomarkers | |||||||||
| C-reactive protein (mg/L) | 2.1 (0.8–5.2) | 1.4 (0.6–3.6) | <0.001 | 1.2 (0.5–3.8) | 1.0 (0.4–2.6) | 0.06 | 2.8 (1.4–6.0) | 2.0 (0.8–4.3) | <0.001 |
| Fibrinogen (mg/dl) | 325 (281–377) | 356 (303–401) | 0.024 | 322 (283–380) | 356 (298–402) | 0.554 | 330 (276–377) | 357 (311–402) | 0.004 |
| Homocysteine (μmol/L) | 7.9 (6.3–9.4) | 8.1 (6.3–10.0) | 0.53 | 8.7 (6.6–10.1) | 8.5 (6.4–11.0) | 0.614 | 7.5 (6.0–8.8) | 7.9 (6.2–9.6) | 0.1 |
| B-type natriuretic peptide (pg/ml) | 18.0 (11.0–35.0) | 28.0 (14.0–52.3) | <0.001 | 28.0 (15.5–64.0) | 37.0 (20.5–97.5) | 0.002 | 15.5 (9.0–25.3) | 22.0 (12.0–41.0) | <0.001 |
| Insulin (ìU/L) | 14.5 (9.8–25.3) | 12.0 (9.0–18.3) | <0.001 | 13.0 (9.0–24.5) | 12.0 (8.5–17.0) | 0.021 | 17.0 (10.5–27.0) | 13.0 (9.0–19.5) | <0.001 |
| Fasting glucose (diabetics) ‡ | 118 (103–148) | 103 (96–121) | <0.001 | 118 (103–152) | 104 (99–146) | 0.20 | 118 (102–149) | 102 (94–120) | <0.001 |
| Hemoglobin A1c (diabetics) ‡ | 6.5 (6.1–7.8) | 6.1 (5.8–7.0) | <0.001 | 6.9 (6.4–8.9) | 6.7 (6.4–8.3) | 0.05 | 6.4 (6.1–7.5) | 6.0 (5.8–6.5) | <0.001 |
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