Disorders of Lipid Metabolism and Cholesterol
To determine the effect of dietary intake of low-fat foods containing natural nonesterified plant sterols together with recommended doses of Ca, Mg and K on serum TC and LDL-C in persons with mild to moderate hypercholesterolemia
Serum cholesterol between 6 – 8 mmol/L (232-310 mg/dl) and TG < 4 mmol/L (356 mg/dl)
Familial hypercholesterolemia, no lipid-lowering or antidiabetic drugs, corticosteroids, androgens or immunosuppressants, history of CVD or uncontrolled HTN in past 3 mos, any revascularization procedure in past 6 mos.
Screening (-5 weeks): stopped meds, received individual dietary advice
Baseline: fasting blood sample, 3-day food record
Placebo Run-In Phase (2 weeks): received same amts of bread, sausage and yogurt, 3-day food record, fasting blood sample
Randomization: assigned to placebo or treatment group receiving 1.25, 2.5 and 5.0 g/day plant sterols during each 5 week period for 15 weeks, fasting blood sample
5, 10 and 15 weeks: 3 day food records, fasting blood samples
TC, TG, HDL-C, LDL-C by Friedewald eqn. Double blind
93 eligible, 78 subjects aged 25 – 75 years were randomized, 71 completed the trial. Clinical characteristics and serum lipid and lipoprotein values were similar between groups.
Overall, daily changes in intake of various minerals in the active group compared with placebo group were 40% increase in Mg, 15% increase in K, 5% increase in Ca, 11% decrease in Na.
Serum TC and LDL-C decreased significantly in the active group compared to the placebo group, whereas there were no changes in HDL-C or TG concentrations.
Reduction in serum TC was 8% in the active treatment group and 3% in the placebo group (p = 0.0071) and that of LDL-C was 13% in the active treatment group and 5% in the placebo group (p = 0.0070).
Our results demonstrate that nonesterified natural plant sterols, incorporated in low-fat food items according to the current methods, are similarly effective in lowering of serum cholesterol. In conclusion, natural nonesterified plant sterols contained in low-fat food items and ingested in moderate doses reduced serum TC and LDL-C concentrations to the same extent as reported previously for esterified plant sterol derivatives added to nutritional fats. The presence of mineral nutrients in doses recommended for blood pressure-lowering did not interfere with the cholesterol-lowering efficacy of the sterols, providing a promising approach to dietary prevention of cardiovascular diseases.
Government: | TEKES |
University/Hospital: | Helsinki University Hospital, Public Health Institute, Oulu Deaconess Institution Hospital |
Well controlled study. Author notes that according to food diaries, actual amount of plant sterols was 0.91, 1.86, and 4.17 g/day.
Quality Criteria Checklist: Primary Research
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Relevance Questions | |||
1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | N/A | |
Validity Questions | |||
1. | Was the research question clearly stated? | Yes | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | N/A | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | N/A | |
1.3. | Were the target population and setting specified? | N/A | |
2. | Was the selection of study subjects/patients free from bias? | Yes | |
2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | N/A | |
2.2. | Were criteria applied equally to all study groups? | N/A | |
2.3. | Were health, demographics, and other characteristics of subjects described? | N/A | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | N/A | |
3. | Were study groups comparable? | Yes | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | N/A | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | N/A | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | N/A | |
3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
4. | Was method of handling withdrawals described? | Yes | |
4.1. | Were follow-up methods described and the same for all groups? | N/A | |
4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | N/A | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | N/A | |
4.4. | Were reasons for withdrawals similar across groups? | N/A | |
4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
5. | Was blinding used to prevent introduction of bias? | Yes | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | N/A | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | Yes | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | N/A | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | N/A | |
6.6. | Were extra or unplanned treatments described? | N/A | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | N/A | |
6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
7. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | N/A | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | N/A | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | N/A | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | N/A | |
7.5. | Was the measurement of effect at an appropriate level of precision? | N/A | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | N/A | |
7.7. | Were the measurements conducted consistently across groups? | N/A | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | N/A | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | N/A | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | N/A | |
8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | N/A | |
8.6. | Was clinical significance as well as statistical significance reported? | N/A | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | N/A | |
9.2. | Are biases and study limitations identified and discussed? | N/A | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | N/A | |
10.2. | Was the study free from apparent conflict of interest? | N/A | |