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FNOA: Antioxidants (2011-2012)

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

To examine the effect of Pycnogenol on biochemical and cognitive measures in healthy elderly individuals.

Inclusion Criteria:

Volunteers aged 60 to 85 years

Exclusion Criteria:
  • Participants taking prescription medications or suffering from clinical pathologies
  • Participants who used anti-coagulants, anti-psychotics, anti-depressants, anxiolytics, or β-blockers
  • Participants with advanced stages of cognitive decline or evident dementia
  • Participants who reported recent use of medications or supplements intended to improve memory or other aspects of cognitive performance in elderly populations
  • Participants whose medical history included clinical conditions that would affect plasma concentrations of lipid peroxidation products
  • Participants with inflammatory or rheumatologic disease, cancer, myocardial infarction or ischaemic incidents, cerebrovascular incident, diabetes, chronic hepatic disease, alcoholism, and smoking
  • Participants with long-term use of medicinal or dietary supplements that could have pro- or anti-oxidative effects (e.g. multivitamins).
Description of Study Protocol:

Recruitment

Volunteers recruited to participate, recruitment methods not described.

Design

Non-randomized controlled trial, matched-pair design 

Blinding used 

Double-blind 

Intervention

Participants consumed a daily dose of 150mg of Pycnogenol for a three-month treatment period or placebo

Statistical Analysis

  • The study used a repeated measures design, cognitive and biological data were subjected to split-plot analysis of variance with treatment group as the between-subjects variable and testing time as the within-subjects variable
  • Outcome variables from the cognitive data were screened for outliers, defined as values existing outside ±3 standard deviations from the mean.
Data Collection Summary:

Timing of Measurements

Participants were assessed at baseline, then at one, two and three months of the treatment.

Dependent Variables

  • Biological measures assessed through standard laboratory methods and comprised:
    • Clinical hepatic enzymes
    • Serum lipid profile
    • Human growth hormone
    • Lipid peroxidation products
  • Cognitive tasks measured through computerized CDR program and comprised:
    • Measures of attention
    • Working memory
    • Episodic memory
    • Psychomotor performance.

Independent Variables

  • Daily dose of 150mg of Pycnogenol for a three-month treatment period or placebo
  • Compliance maintained by giving all participants their monthly supplies of pills in purpose-designed dosage boxes.

Control Variables

  • Age
  • Sex
  • BMI
  • IQ measured through Wechsler Abbreviated Scale of Intelligence (WASI)
  • Dietary intake of antioxidants and associated micronutrients measured through food frequency questionnaire. 
Description of Actual Data Sample:
  • Initial N: 120 volunteers were screened and entered into the trial
  • Attrition (final N): 101 elderly participants
    • 46 men and 55 women
    • 49 in the Pycnogenol group and 52 in the control group
    • Eight were lost to follow-up and 11 withdrew of their own consent
  • Age: Aged 60-85 years, mean age 67.8 years
  • Ethnicity: Not reported
  • Other relevant demographics:
  • Anthropometrics: The groups were matched by age, sex, BMI, micronutrient intake and intelligence
  • Location: Australia.
Summary of Results:

Key Findings

  • Statistically significant interactions were found for memory-based cognitive variables and lipid peroxidation products, with the Pycnogenol group displaying improved working memory and decreased concentrations of F2-isoprostanes relative to the control group
  • ANOVA revealed a significant interaction between testing time and treatment group for the quality of working memory and spatial working memory (P<0.01) after three months, but post hoc comparisons revealed no differences between groups at earlier months
  • No significant interaction between treatment group and testing time was observed for numeric working memory, power of concentration or any other cognitive tasks
  • There were no differences between groups in terms of liver function enzymes, serum lipid profile, postprandial glucose levels, or human growth hormone.
Author Conclusion:

The findings of this study suggest that a three-month intake of Pycnogenol has beneficial cognitive and biochemical effects for elderly individuals.

Funding Source:
Industry:
Horphag Pty Ltd
Pharmaceutical/Dietary Supplement Company:
In-Kind support reported by Industry: Yes
Reviewer Comments:

Sponsored by Horphag, the manufacturer of Pycnogenol. Study only three months long.

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? ???
  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? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
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) No
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  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? Yes
  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%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? ???
  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? Yes
  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.) Yes
  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? ???
  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? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  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? N/A
  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? ???
  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? Yes
  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)? Yes
  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? No
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? No