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Original Research Communications |
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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Objective: The objective of this study was to evaluate the effects of the National Cholesterol Education Program's Step I and Step II dietary interventions on major cardiovascular disease risk factors using meta-analysis.
Design: MEDLINE was used to select 37 dietary intervention studies in free-living subjects published from 1981 to1997.
Results: Step I and Step II dietary interventions significantly decreased plasma lipids and lipoproteins. Plasma total cholesterol (TC), LDL cholesterol, triacylglycerol, and TC:HDL cholesterol decreased by 0.63 mmol/L (10%), 0.49 mmol/L (12%), 0.17 mmol/L (8%), and 0.50 (10%), respectively, in Step I intervention studies, and by 0.81 mmol/L (13%), 0.65 mmol/L (16%), 0.19 mmol/L (8%), and 0.34 (7%), respectively, in Step II intervention studies (P < 0.01 for all). HDL cholesterol decreased by 7% (P = 0.05) in response to Step II but not to Step I dietary interventions. Positive correlations between changes in dietary total and saturated fatty acids and changes in TC and LDL and HDL cholesterol were observed (r = 0.59, 0.61, and 0.46, respectively; P < 0.001). Multiple regression analyses showed that for every 1% decrease in energy consumed as dietary saturated fatty acid, TC decreased by 0.056 mmol/L and LDL cholesterol by 0.05 mmol/L. Moreover, for every 1-kg decrease in body weight, triacylglycerol decreased by 0.011 mmol/L and HDL cholesterol increased by 0.011 mmol/L. Exercise resulted in greater decreases in TC, LDL cholesterol, and triacylglycerol and prevented the decrease in HDL cholesterol associated with low-fat diets.
Conclusion: Step I and Step II dietary interventions have multiple beneficial effects on important cardiovascular disease risk factors.
Key Words: National Cholesterol Education Program • NCEP Step I diet • NCEP Step II diet • total cholesterol • LDL cholesterol • HDL cholesterol • triacylglycerol • body weight • risk factors • cardiovascular disease • exercise • meta-analysis • humans
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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See corresponding editorial on page 581.
Controlled feeding studies have consistently found that a reduction in dietary SFA decreases plasma total and LDL-cholesterol concentrations. In general, a Step I diet decreases plasma total cholesterol and LDL cholesterol by 
7–9% compared with the average American diet. A Step II diet has been shown to decrease total cholesterol and LDL cholesterol by 10–20% (1, 2). In controlled feeding studies in which body weight was maintained, low-fat diets often were associated with decreases in HDL cholesterol and increases in triacylglycerol (2–4). A low HDL-cholesterol concentration and an elevated triacylglycerol concentration are both risk factors for CVD (4). In contrast with these potentially adverse effects of low-fat diets on HDL-cholesterol and triacylglycerol concentrations, which have been reported in well-controlled clinical feeding studies, a body of evidence from dietary intervention studies conducted in free-living populations has shown that low-fat diets are typically accompanied by weight loss, and often other risk-factor modifications result in a decrease in plasma total cholesterol, LDL cholesterol, and triacylglycerol, and no change in HDL cholesterol (5–15). Likewise, many free-living populations worldwide consume very-low-fat diets and have a favorable lipid profile, which likely is due to their lifestyle practices, including regular physical activity and maintenance of an ideal body weight (16, 17).
Many primary and secondary intervention studies have evaluated how different intervention strategies to reduce the risk of CVD, including diet modification, affect various CVD risk factors in free-living subjects. In general, the responses in these intervention studies have been quite variable. For example, some studies have shown that dietary intervention and other risk-factor modifications often accompanied by weight loss reduce plasma total cholesterol, LDL cholesterol, as well as triacylglycerol, but increase or have no significant effects on HDL cholesterol (5–15). Other intervention studies, however, found that low-fat diets resulted in an increase in plasma triacylglycerol and a decrease in HDL cholesterol (18–22). Thus, the purpose of the present study was to evaluate the effects of different dietary interventions on major CVD risk factors in healthy and high-risk subjects by conducting a meta-analysis.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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30% of total energy as fat, 10% of energy as SFA, and 300 mg dietary cholesterol/d), a Step II diet (7% of energy as SFA and 200 mg dietary cholesterol/d), or both were part of the dietary intervention; 4) the subjects were free-living, prepared their own food, and were counseled by dietitians or other professionals about implementing low-fat diets; and 5) the intervention lasted 
3 wk to stabilize plasma cholesterol concentrations.
Statistical analysis
Changes in plasma total cholesterol, LDL cholesterol, HDL cholesterol, and triacylglycerol after Step I and Step II dietary interventions were assessed. Effects of exercise and body weight were evaluated. In addition, effects of baseline plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol concentrations on lipid responses were also analyzed. We also examined the relation between changes in body weight and changes in dietary fat and energy consumption. All analyses were done by using the SAS statistical package (44).
In each study, plasma lipid concentrations after dietary intervention were compared with lipid concentrations in the control groups as well as with baseline lipid concentrations. Changes in plasma lipid concentrations and in dietary fat or cholesterol were calculated by using the difference between a treatment group and a control group or differences between intervention and baseline values in the intervention groups. Analysis of variance was used to compare the effects of Step I with those of Step II dietary interventions and the effects of interventions including exercise with those not including exercise. Correlations between changes in plasma lipid concentrations (both absolute and percentage changes) and changes in total fat and SFA intakes (as a percentage of total daily energy intake) and changes in dietary cholesterol (mg/d) and changes in body weight (kg) were evaluated by Pearson correlation analysis.
Changes in plasma total cholesterol, LDL cholesterol, HDL cholesterol, and triacylglycerol in response to changes in body weight and in dietary total fat, SFA, and cholesterol were evaluated by regression analysis. In each study, the differences in plasma lipid concentrations between intervention and control groups (or between baseline and intervention values) were used as dependent variables and the differences in dietary total fat, SFA, and cholesterol as independent variables. Changes in body weight in the intervention groups were used as a covariable in the regression analysis. Both bivariate and multiple regression analyses were conducted. Bivariate regression analysis included the change (
) in 1 independent variable (TF, SFA, or cholesterol) and 1 covariable (BW); multiple regression analysis included the change in 2 independent variables (TF and cholesterol or SFA and cholesterol) and 1 covariable (BW). The equations are as follows:
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| (1) |
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| (2) |
where BW is body weight and TF is total fat. The coefficients (ß1, ß2, and ß3) were estimated by least-squares regression.
Changes in body weight in response to changes in dietary total fat intake were tested by regression analysis and Pearson correlation analysis. In the regression analysis, the change in body weight after intervention was used as a dependent variable and the change in total fat intake was used as an independent variable. The regression equation is as follows:
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| (3) |
Correlation between change in body weight and change in fat was evaluated using the Pearson correlation analysis conducted with and without using subject number as a weight factor from each study.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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30% of energy as fat, <10% of energy as SFA, and 300 mg cholesterol/d. The diet compositions and study designs of the interventions are summarized in Table 1
; 8 studies evaluated the effects of diet on body weight. Despite the differences in experimental design and populations studied, total cholesterol decreased by 2–25% as a result of dietary and other risk-factor interventions. Lipid concentration data from 30 studies before and after intervention are summarized in Table 2.
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). The length of intervention ranged from 3 wk to 4 y. Intervention intensity was moderate to high and 13 studies included an exercise intervention.
Mean baseline total cholesterol and LDL-cholesterol concentrations were between 4.84 and 6.88 mmol/L (
± SE: 6.04 ± 0.53 mmol/L) and 3.05 and 4.55 mmol/L (4.01 ± 0.46 mmol/L), respectively, except in the study of Hjermann et al (5) in which subjects had higher baseline concentrations of total cholesterol (8.47 mmol/L) and LDL cholesterol (6.78 mmol/L). Mean baseline HDL-cholesterol concentrations were between 0.72 and 1.72 mmol/L (1.24 ± 0.23 mmol/L) and triacylglycerol concentrations were between 0.85 and 2.51 mmol/L (1.67 ± 0.46 mmol/L). Most studies had more than one endpoint blood collection. Some studies (24, 25, 30, 34) did not have complete plasma lipid data. For example, 2 studies (24, 30) did not report plasma LDL-cholesterol, HDL-cholesterol, and triacylglycerol concentrations and 1 study (25) did not report baseline plasma lipid concentrations (Table 2). A total of 59 dietary intervention groups yielded 59 data points for the regression and correlation analyses.
Comparison of the effects of Step I and Step II dietary interventions on plasma lipids
Plasma total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerol, and total cholesterol:HDL cholesterol all decreased after both Step I and Step II dietary interventions, by 0.63 ± 0.06 mmol/L (10%), 0.49 ± 0.05 mmol/L (12%), 0.04 ± 0.02 mmol/L (1.5%), 0.17 ± 0.04 mmol/L (8%), and 0.50 ± 0.11 (10%), respectively, after the Step I dietary interventions (P < 0.01 for all, except for HDL cholesterol ) and by 0.81 ± 0.12 mmol/L (13%), 0.65 ± 0.09 mmol/L (16%), 0.09 ± 0.03 mmol/L (7%), 0.19 ± 0.14 mmol/L (8%), and 0.34 ± 0.12 (7%), respectively, after the Step II dietary intervention studies (P < 0.01 for all). The Step II dietary intervention resulted in greater decreases in plasma total cholesterol (P < 0.05), LDL cholesterol (P < 0.05), HDL cholesterol (P = 0.13), triacylglycerol (P = 0.37), and total cholesterol:HDL cholesterol (data not shown) than did the Step I dietary intervention (Figure 1). When analyses were weighted by the number of subjects in each study, plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol concentrations decreased by 21%, 21%, 13%, and 33%, respectively, after Step II dietary interventions. Plasma total cholesterol, LDL-cholesterol, and triacylglycerol concentrations decreased by 8%, 8%, and 10%, respectively, after Step I dietary interventions; HDL cholesterol increased by 2%. Decreases in plasma lipids and lipoproteins were much greater after the Step II dietary interventions than after Step I dietary interventions (P < 0.001). Interestingly, plasma lipid and lipoprotein responses of males and females were comparable after both Step I and Step II dietary interventions (data not shown), with one notable exception. The decrease in HDL cholesterol was greater in women (0.10 mmol/L, 6.8%) than in men (0.03 mmol/L, 2.2%) (P < 0.05) after the Step II intervention. In addition, triacylglycerol concentrations tended to increase in women by 0.01 mmol/L (2.4%) and 0.07 mmol/L (5.4%) and decrease in men by 0.21 mmol/L (10.4%) and 0.03 mmol/L (1.5%), respectively, after Step I and Step II dietary interventions. In addition, most lipid responses were comparable after interventions lasting <6 mo and those after interventions lasting >6 mo (data not shown). The only exception was that HDL-cholesterol concentrations decreased by 0.09 mmol/L (6.4%) and by 0.13 mmol/L (9.7%), respectively, after Step I and Step II interventions lasting <6 mo and increased by 0.03 mmol/L (4.7%) after Step I interventions and decreased by only 0.01 mmol/L (0.5%) after Step II interventions lasting >6 mo (P < 0.05).
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) and SFA (Figure 3). The correlation between the change in plasma triacylglycerol and the change in dietary fat and SFA was not significant. Changes in total cholesterol, LDL cholesterol, HDL cholesterol, and triacylglycerol (both absolute and percentage changes) were significantly correlated with changes in dietary cholesterol (Table 3). When Pearson correlation analyses were weighted by the number of subjects in each study, all correlation coefficients were significant.
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). For example, every 1% decrease in energy from dietary total fat decreased total cholesterol by 0.06 mmol/L (0.9%), LDL cholesterol by 0.042 mmol/L (1.04%), and HDL cholesterol by 0.01 mmol/L (0.79%). The regression analysis showed that changes in body weight significantly affected plasma HDL-cholesterol and triacylglycerol concentrations. For example, with dietary total fat as a variable and body weight as a covariable, every 1-kg increase in body weight increased plasma triacylglycerol by 0.041 mmol/L (1.14%) and decreased HDL cholesterol by 0.01 mmol/L (0.83%). The regression coefficients of body weight for changes in total cholesterol and LDL cholesterol were not significant (data not shown).
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). For example, every 1% decrease in energy from dietary SFA resulted in a decrease in total cholesterol by 0.056 mmol/L (0.77%), LDL cholesterol by 0.05 mmol/L (1.07%), and HDL cholesterol by 0.012 mmol/L (0.6%). Dietary cholesterol had significant effects on total cholesterol, LDL cholesterol, and possibly triacylglycerol, but not on HDL cholesterol. The regression coefficients of dietary total fat and SFA for triacylglycerol were not significant. Body weight change was shown again to have significant effects on HDL cholesterol and triacylglycerol. With every 1-kg decrease in body weight, plasma triacylglycerol concentrations decreased by 0.011–0.012 mmol/L (0.77–0.87%), whereas HDL-cholesterol concentrations increased by 0.011 mmol/L (1%) (Table 5). The regression coefficients for body weight change and changes in total cholesterol and LDL cholesterol were not significant (data not shown).
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Effects of exercise on plasma lipids
In the present study, we included 14 intervention groups with exercise and 45 intervention groups without exercise. Analysis of variance showed that exercise had significant effects on plasma lipids and lipoproteins. Plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol concentrations decreased by 0.60 ± 0.06, 0.47 ± 0.05, 0.06 ± 0.02, and 0.11 ± 0.04 mmol/L, respectively, in intervention groups without exercise and decreased by 0.78± 0.13, 0.56 ± 0.12, 0.01 ± 0.04, and 0.35 ± 0.12 mmol/L in intervention groups with exercise (Figure 4). Exercise groups had a greater decrease than nonexercise groups in plasma total cholesterol (13% compared with 10%), LDL cholesterol (15% compared with 11%), and triacylglycerol (17% compared with 5.2%), but no significant change in HDL cholesterol was observed between exercise and nonexercise groups. When the analyses were weighted by a subject number from each study, the exercise groups had as much as a 3-fold greater decrease in total cholesterol (by 1.27 compared with 0.43 mmol/L, 21% compared with 7%) and LDL cholesterol (by 0.83 compared with 0.29 mmol/L, 21% compared with 7%), a 5-fold greater decrease in triacylglycerol (by 0.77 compared with 0.11 mmol/L, 33% compared with 6%), and a 10-fold smaller decrease in HDL-cholesterol concentrations (by 0.015 compared with 0.145 mmol/L, 0.02% compared with 5.1%) (P < 0.0001 for all comparisons) than the nonexercise groups.
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). The change in total cholesterol was not correlated with the baseline concentration (Figure 5). However, if baseline total cholesterol concentrations were <6.2 mmol/L, the change in total cholesterol was significantly correlated with baseline concentrations (r = 0.591, P < 0.001). In contrast, no relation was observed in subjects with an initial total cholesterol concentration >6.2 mmol/L (data not shown). A similar relation was observed for LDL cholesterol (data not shown). Thus, it appears that individuals with marked elevations in total cholesterol and LDL cholesterol were less responsive to dietary interventions than were mildly to moderately hypercholesterolemic individuals.
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) as well as with the change in energy intake. The change in dietary fat was related to the change in energy intake. Regression analysis showed that the change in dietary fat had a significant effect on the change in body weight.
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| (4) |
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Diet intervention with exercise resulted in significantly greater weight loss than diet intervention without exercise. Body weight decreased by 5.66 ± 0.77 kg in intervention groups with exercise and by 2.79 ± 0.31 kg in intervention groups without exercise (Figure 7). Furthermore, there was no significant difference in the change in dietary fat between intervention groups with and without exercise (-11.6 ± 1.9% compared with -10.0 ± 0.7% of total energy, P > 0.05). Thus, the effect of change in dietary fat on body weight was independent of the effect of exercise.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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; r = 0.63, P < 0.0001), and HDL cholesterol (– • • – 
; r = 0.41, P < 0.001), but not for triacylglycerol (•••••••• 
; r = 0.19, P = 0.47).
