DF: Cardiovascular Disease (2008)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • To examine if oats consumption lowers blood total cholesterol level
  • To evaluate the effect of potential modifiers and confounders (age, gender, oats dose, initial blood cholesterol level) in the association between oats consumption and blood total cholesterol level.
Inclusion Criteria:

Below are inclusion criteria for studies to be considered in this review:

  • Identified from Medline search until March 1991, inquiries to list of all known investigators in the lipid-oats association (list provided by Quaker Oats), lists of unpublished trials
  • Trials had to be controlled and randomized
  • There must be at least four weeks between dietary intervention and blood lipid assessment
  • Control group has to be very low or no soluble fiber
  • Dietary intake must be formally assessed
  • Weight changes must be evaluated
  • Primary study investigators must agree to release raw data
  • Must measure oats intake and total cholesterol concentration
  • Must investigate individual effect of oats apart from other intervention.

 

Exclusion Criteria:

None except not meeting inclusion criteria.

Description of Study Protocol:

Recruitment

Studies were identified from Medline search until March 1991. Unpublished trials were identified by inquiring investigators known to be familiar in the lipid-oats association, according to a list of investigators provided by Quaker Oats. Then, investigators of these studies were contacted to obtain raw data.

Design

Meta-analysis and pooled analysis.

Statistical Analysis

Meta-regression using random-effects model, test of heterogeneity.

 

Data Collection Summary:

Timing of Measurements

Medline search was done until March 1991.

 Dependent Variables

  • Change in total cholesterol level
  • Keys score: Calculated using changes in saturated fatty acids, polyunsaturated fatty acids, dietary cholesterol and energy intake.

Independent Variables

Soluble fiber intake (g). 

Control Variables:

  • Age (less than 50 years vs. 50 years or older)
  • Gender
  • Preliminary cholesterol level, which is the mean total cholesterol level before intervention.
Description of Actual Data Sample:

For summary effect size calculation, N=12 studies were included, providing 22 treatment-control comparisons:

  • Eight trials were parallel
  • Three were two-by-two crossover design of oat bran and wheat bran
  • One was three-by-three design using oat bran, rice bran and wheat bran
  • Two trials measured apo A-I and apo B in addition to total cholesterol and LDL.

Characteristics of Studies

  • Subject age range: 20 to 73 years
  • Duration of studies: 18 days to 12 weeks
  • Sample size range: 10 to 137 subjects
  • Dietary assessment used: Majority of trials used three- or four-day food record.

 

 

Summary of Results:

Summary Effect Estimates of Oats Consumption on Total Cholesterol, Per Different Groups of Studies

Inclusion Criteria Number of Primary Data Sets X-square P-value, Testing that Within-effect Size Variance is Equal to Between-effect Size Variance Summary Effect Size (mmol per L) 95% CI (mmol per L)
A priori criteria 19 26.5 0.1 -0.15 -0.22 to -0.09
Broadened criteria 22 25.8 0.2 -0.13 -0.19 to -0.07
A priori criteria, but exclude multiple use of treatment groups 17 21.3 15 -0.16 -0.22 to -0.09
Broadened criteria, but exclude multiple use of treatment groups 19 22.7 0.2 -0.14 -0.20 to -0.09
A priori criteria, with only trials where wheat bran was the control 12 16.3 0.2 -0.22 -0.35 to -0.1
A priori criteria, with only trials where control groups had no comparison product 7 8.5 0.2 -0.11 -0.18 to -0.04

Effect Size for Change in Total Cholesterol Level by Dose and Initial Cholesterol Level

Intervention Dose

Effect Size When Initial Cholesterol Level Less than 5.9mmol per L

Effect Size When Initial Cholesterol Level of 5.9mmol or more per L

Less than 3.0g of soluble fiber from oats

-0.09±0.10

(N=6)  

-0.27±0.04

(N=4)

3.0g or more of soluble fiber from oats

-0.13±0.12

(N=3)

-0.41±0.21

(N=6)

  • Beneficial effects are more profound in population with higher baseline cholesterol level
  • According to Keys score or 0.63 (P=0.001), replacing dietary fats and cholesterol with carbohydrates did not explain the reduction in blood cholesterol
  • Gender, age and gender-age interaction term did not predict the change in effect size.
Author Conclusion:
  • About 3g per day of soluble fiber intake from oat products can decrease total cholesterol level 0.13 to 0.16mmol per L
  • Effect of oats intake is greater among those with high initial blood cholesterol levels.
Funding Source:
Industry:
Quaker Oats Company
Food Company:
Reviewer Comments:
  • It is not clear to me how the "more rigorous" and "broadened" inclusion criteria differ
  • According to the authors, analysis were conducted using one treatment-control comparison as unit of analysis. Therefore, some studies contributed more than once. There is no evidence showing whether this correlation may or may not have impacted the results.
  • There was no quality grading for primary studies.
  • Search strategy and search terms were not described. Only one electronic database was searched. List of potential investigators was provided by industry and profit organizations and may be potentially biased.
Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? Yes
 
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? No
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? ???
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? No
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? Yes
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? Yes
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? Yes
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? No
  10. Was bias due to the review's funding or sponsorship unlikely? No