*6.2.1 Nutritional data in the intervention and control group*

**Table 5** shows the comparison of nutritional data in the intervention and control groups at the end of the study (27 months after the randomization) [82, 195, 196].


#### **Table 5.**

*Comparison of nutritional data in the intervention and control groups in the Lyon Diet Heart study at the end of the study (27 months after the randomization) [82, 195, 196].*

## *Effects and Issues of Diet Fat on Cardiovascular Metabolism DOI: http://dx.doi.org/10.5772/intechopen.93261*

reason for this inconsistency is the type of MUFA in the studies. It seems clear that substitution of SFA with olive oil consistently reduced CV events, meaning that it is necessary to recognize the different metabolic effects between olive oil and other

Despite the small decreases in LDL-cholesterol (usually <5%) with the Mediterranean diet food, in meta-analysis of many cohort studies, the magnitude of decreases in CV events was to the same extent or even larger than in statin studies [192–194]. Effects on CV events beyond LDL-cholesterol reduction with the Mediterranean diet has been demonstrated in two RCTs, the Lyon Diet Heart study and the PREDIMED study [6]. The Lyon Diet Heart study [82, 195], which was the first RCT of the Mediterranean diet before the statin era, randomized 605 patients with history of myocardial infarction to compare that diet with a French style diet. The

*P* = 0.001). The overall mortality was also reduced by 70% (CI: 0.11–0.82, *P* = 0.02). Although the study was originally planned to follow CV events for 5 years, it was terminated early, 2 years and 3 months after the study initiation, due to the high mortality rate in the control group. There were no significant differences in body weight, blood pressure, LDL and HDL cholesterol, and blood glucose levels between the two diet groups at the end of the study. Therefore, the marked differences in rates of CV events were not due to improvement of these classical surrogate risk markers. The investigators presented results of an extended follow-up, and the

**Table 5** shows the comparison of nutritional data in the intervention and control groups at the end of the study (27 months after the randomization) [82, 195, 196].

Total lipids, *E*% 33.6 30.4 0.002 <30 <30 SFA, *E*% 11.7 8.0 0.0001 8–10 <7 PUFA, *E*% 6.1 4.6 0.0001 up to 10

Oleic (MUFA), *E*% 10.8 12.9 0.0001 up to 15

Fiber, g 15.5 18.6 0.004 20–30 Cholesterol, mg 312 203 0.0001 <300 <200

*Comparison of nutritional data in the intervention and control groups in the Lyon Diet Heart study at the end*

**Control Intervention** *P* **To maintain desirable BW**

**Step 1 Step 2**

Mediterranean diet reduced the primary endpoint by 73% (CI: 0.12–0.59,

striking reduction of CV evens was maintained for up to 4 years [195].

*6.2.1 Nutritional data in the intervention and control group*

Energy, cal 2088 1947 0.033

Linolenic (n-3), *E*% 0.29 0.84 0.0001 Linoleic (n-6), *E*% 5.3 3.6 0.0001

Carbohydrate, *E*% 49.8 53.4 N/A Protein, *E*% 16.6 16.2 0.3

*of the study (27 months after the randomization) [82, 195, 196].*

**Table 5.**

**94**

oils that contain MUFA.

**6.1 Lyon Diet Heart study**

*New Insights into Metabolic Syndrome*

**6.2 Results of the Lyon Diet Heart study**

In order to show the uniqueness of the intervention group in this Lyon Diet Heart study, the nutrient profiles of the NECP/AHA step 1 and step 2 are also presented. Because the intake of calories and the percentages of energy (*E*%) of three major nutrients were relatively similar, it appears that the differences in fat components had substantial effects on CV events. In the Mediterranean diet group, SFA was 32% lower (8.0 vs. 11.7%), oleic acid (MUFA) was 20% higher (12.9 vs. 10.8%), and αlinolenic acid (n-3 PUFA) was 190% higher (0.84 vs. 0.29%). Because there was no restriction of butter, fatty red meat, or snacks (rich sources of SFA) in the control diet group, and animal meat has also high content of MUFA, the energy percentage of SFA was high in the control diet group and the total unsaturated fat (MUFA + PUFA) was not different between the two groups (control vs. Mediterranean: 16.9 vs. 17.5%). The change in fat components in the Mediterranean diet group was not in accord with the current general recommendations regarding SFA and PUFA. The group had relatively high intake of SFA (8%) and lower intake of PUFA than in the control group (4.6 vs. 6.1%, **Table 4**), which could explain the small change in LDL cholesterol by the intervention. The findings in this study clearly illustrate the importance of the risk factors beyond lipids and lipoproteins.

Compared with data in PREDIMED study [6], conducted two decades later, which was loaded with extra-virgin olive oil and nuts with less refined carbohydrate, the percentage of energy of MUFA was almost half (12.9 vs. 22.1%), fat calorie was 10.8% lower (30.4 vs. 41.2%), and inversely, carbohydrate calories were 12.2% higher in the Mediterranean diet group in the Lyon Diet study (53.4 vs. 41.2%). Furthermore, the percent of calories from n-3 PUFA was low compared with those values in the REDUCE-IT [156] and JELIS [163] studies where highly purified marine-derived n-3 EPA was given. Therefore, it is unlikely that the beneficial, biological effects of n-3 PUFA or MUFA on CV risk reduction were maximally utilized for the reduction of CV events in the Lyon Diet Heart study. The very high value of SFA in the control group (11.7%) may be another factor contributing the exaggerated CV event reduction in this study. In one cohort study with 2.96 million person-years of follow-up which evaluated effects of red meat consumption on risk of CV diseases [197], the total mortality in the top quintile was 40% higher than in the bottom quintile. SFA consumption in the control group in the Lyon Diet Heart study was almost identical to that in the top quintile in that cohort study. At present, as SFA is well known to increase in LDL cholesterol, it is nearly impossible to conduct any diet trials with more than 8% intake of SFA for ethical reasons.
