Clinical studies
Randomized trial of the effects of cholesterol-lowering dietary treatment on psychological function,

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Abstract

PURPOSE: Epidemiological studies have suggested that cholesterol lowering could affect psychological functioning. This study was designed to test whether cholesterol-lowering diets adversely affect mood and cognitive function.

SUBJECTS AND METHODS: We randomly assigned 176 adults with elevated serum cholesterol levels (>5.2 mM [198 mg/dL]) to either a low-fat diet, a Mediterranean diet, or a waiting-list control. Cholesterol levels, psychological well-being (depression, anxiety, hostility), and cognitive function were assessed at baseline, 6 weeks, and 12 weeks.

RESULTS: Total serum cholesterol levels fell significantly more in the intervention groups (8.2% reduction) than in the control group (P <0.001). All three groups showed a modest improvement in psychological well-being during the 12-week treatment period, but there were no differences among the groups. There were no between-group differences on three measures of cognitive function, but for a fourth measure, which involved the task with the greatest processing load, the two intervention groups did significantly worse (P <0.001) than the control group. The change in performance was correlated with the change in total serum cholesterol level (r = 0.21, P = 0.01).

CONCLUSIONS: Two dietary interventions that successfully lowered serum cholesterol levels had no adverse effect on mood. There was some evidence for a relative impairment in cognitive function in the treated groups in one of four cognitive tests, but additional studies will be required to determine the relevance of this finding.

Section snippets

Participants and design

Adults with mildly or moderately raised serum cholesterol levels were referred by hospital dietetic clinics, hospital physicians, and general practitioners in London and Southeast England. Participants were required to have a serum cholesterol level >5.2 mM (198 mg/dL); no serious illness (except cardiovascular disease, for which cholesterol lowering was indicated); no current or previous (within 3 months) use of lipid-lowering medication; and physician’s permission to participate. In addition,

Results

Of the 176 participants who began treatment, 155 completed the posttreatment assessment and had attended at least four treatment sessions (Figure 1). Participants were generally middle-aged and somewhat overweight (Table 1). Nutrient analyses from the 7-day diaries showed that reported energy intakes were reasonable for adults of this age, as were levels of depression, anxiety, and aggression. There were no significant differences among the three treatment groups in any of the baseline

Discussion

The participants in this study were adults with at least mild hypercholesterolemia by UK criteria. As volunteers who agreed to participate in a relatively demanding study, participants were probably more highly motivated than the population at large, but that is true in most clinical trials. Many of the participants were already following a low-fat diet, and the recorded fat intake at baseline (32% of energy) was lower than the UK average of 39%. The dropout rate was low, partly because

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