DFA: Linoleic Acid (LA) and Intermediate Health Outcomes (2011)

Study Design:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To investigate the association between dietary intake of  polyunsatured fatty acids (PUFA) and peripheral neuropathy in the US population. 

Inclusion Criteria:
  • At least 40 years of age
  • Self-reported diabetes
  • Peripheral neuropathy diagnosis
  • Completed, reliable 24-hour dietary recall.
Exclusion Criteria:

N/A because data were gathered from the NHANES database from 1999 to 2004.

Description of Study Protocol:


Data was gleaned from the NHANES 1999-2004 database.



Statistical Analysis

  • Descriptive statistics on the dietary intake of PUFA
  • Student's T-test or chi-square test was used for continuous or category variables
  • Quintiles were calculated for PUFA intake
  • A logistic regression model was used to estimate the odds of having peripheral neuropathy among adults in higher PUFA intake quintiles relative to adults in the lowest PUFA intake quintiles.
Data Collection Summary:
  • Timing of measurements: Information from the 1999-2004 NHANES study
  • Dependent variables: Peripheral neuropathy foot sensation test
  • Independent variables: Polyunsaturated fatty acid intake and linolenic intake
  • Control variables: Self-reported diabetes and peripheral neuropathy diagnoses.
Description of Actual Data Sample:
  • Initial N: 1,062 adults
  • Attrition (final N): N/A
  • Age: Over 40 years
  • Ethnicity: Not reported; USA citizens
  • Other relevant demographics: Not reported
  • Location: USA citizens.
Summary of Results:

Key Findings

  1. Adults with peripheral neuropathy were significantly older, taller and more likely to be male, have lower education levels and have longer duration of diabetes than adults without peripheral neuropathy
  2. Among adults with peripheral neuropathy, the mean daily total PUFA itnake was 14.6±0.79g and the mean daily intake of linolenic acid was 1.25±0.07g, which was significantly lower than values among adults without peripheral neuropathy
  3. Relative to adults in Quintile One of total PUFA intake, the odds of having peripheral neuropathy was 0.43 (95% CI, 0.19-1.00) for adults in Qunitile Five, after adjusting for previously identified covariates
  4. Relative to adults in Quintile One of Linolenic acid, the odds of having peripheral neuropathy was 0.54 (0.30-0.99) for adults in Quintile Four and 0.40 (0.21-0.77) for adults in Quintile Five.

Other Findings

  • Only 4.04% of adults reported taking supplements containing PUFAs. The association between taking supplements containing PUFAs and the risk of peripheral neuropathy was not estimated because of small sample size.
  • Diabetes duration did not change the association between PUFA intake and peripheral neuropathy.
Author Conclusion:
  • Among adults with diagnosed diabetes, dietary intake of linolenic acid is associated with lower odds of peripheral neuropathy. More work is needed to study the association between ALA and peripheral neuropathy.
  • These researchers found that the dietary intake of linolenic acid is negatively associated with odds of peripheral neuropahy among adults with diabetes.
Funding Source:
Government: CDC and the Div. of Health and Nutr. Exam Surveys, National Center for Health Statistics
Reviewer Comments:
  • This was a good study, but the article had minimal information: No details were provided about ethnic background, type of diabetes, demographics, gender, etc.
  • The authors did admit that the PUFA intake was based on one 24-hour recall. Thus, some of the adults may have been misclassified with respect to their usual PUFA intake. Another limitation is that only tactile neuropathy was measured. Thus, no statements can be made aobut sensory function.
Quality Criteria Checklist: Primary Research
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) Yes
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? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
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? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
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) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) No
  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? Yes
  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? N/A
  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? Yes
  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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  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.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? No
  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? No
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? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  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? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  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? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? Yes
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? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  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? Yes
  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? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes