FNOA: Antioxidants (2011-2012)
To examine the effect of Pycnogenol on biochemical and cognitive measures in healthy elderly individuals.
Volunteers aged 60 to 85 years
- 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).
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.
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.
- 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.
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.
The findings of this study suggest that a three-month intake of Pycnogenol has beneficial cognitive and biochemical effects for elderly individuals.
Industry: |
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In-Kind support reported by Industry: | Yes |
Sponsored by Horphag, the manufacturer of Pycnogenol. Study only three months long.
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) | 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 | |