EAL

DLM: Plant Stanols and Sterols (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose was to conduct a post-launch monitoring (PLM) program regarding vegetable oil spread designed to lower cholesterol. The PLM assessed typical use of the product, known effects, and unexpected health effects. The study sought to answer three questions:

Is the product used as predicted/recommended?
Are known effects as predicted?
Does the item produce unexpected health effects?

Inclusion Criteria:

Registered households in the UK, The Netherlands, France, Germany and Belgium that were provided by independent market research firms.

Exclusion Criteria:

Not described

Description of Study Protocol:

Recruitment

From independent market research organizations

Design

Cross-sectional

Blinding used

Consumers were blinded as to which of their scanned food items were being monitored during the market research

Intervention

Not applicable

Statistical Analysis

Independent market research firms provided data on consumer product usage. The continuous quantitative method of data collection provides direct information from households
Registered households scanned barcodes of food items they purchased. A centralized database received the information, which specifies what the households bought, when it was bought and the demographics of the buyer
Registered households were identified by age of primary shopper, size of household, socio-economic group, presence of children and geographic region
Data were weighted to fit with population profiles of each country
Panelists received regular questionnaires and were monitored for accurate recording of purchases. Purchase levels were matched to household standards and to households with high compliance.
A world-wide system was developed for the customer care line to collect information in an unbiased manner. Consumer information was confidential.
A clinician and a toxicologist assessed data for causal relationships between product consumption and reported symptoms
A coding system of four colors was used to categorize various levels of association between product intake and reported systems (red, orange, yellow and green). Two additional categories were created for customer calls that were irrelevant and for those that did not have enough information.
- Red: Association between intake of the product and occurrence of symptoms, to be explained by the known molecular properties
- Orange: Association between intake of the product and occurrence of symptoms and cannot be explained by molecular properties but causation cannot be excluded
- Yellow: Association between intake of the product and occurrence of symptoms and cannot be explained by molecular properties but causation can be excluded
- Green: No association between intake of the product and symptoms
A summary of the outcome of the assessment was directed back to the customer care line to assist the customer
All customer calls were monitored to check for possible unexpected side effects. Data review was performed regularly to decide if follow-up studies were needed to further evaluate side effects
The first assessment of data was conducted in March 2001, which included about seven months of data. A second assessment at the end of August 2001 included another five months of data and was used to test for time trends.

Data Collection Summary:

Timing of Measurement

The market survey was conducted from September 2000 to August 2001
Results were reported in January 2002 to the European Commission, with findings being published in October 2002.

Dependent Variables

Post-marketing surveillance is a system that is used to monitor side effects of pharmaceutical products. PMS is not routinely used in testing new food products, but the researchers wanted to assess the tool's efficacy in such a situation.

Independent Variables

The independent variable was intake of vegetable oil spread with added phytosterol-esters (ß-sitosterol, camposterol and stigmasterol). Esterification was performed using fatty acids from sunflower oil.

Control Variables

Not applicable

Description of Actual Data Sample:

Initial N

All registered households in each of the countries

Attrition (final N)

Number of households varied based on country size

Age

Majority were above age 45, but some respondents chose not to provide this information

Other relevant demographics and anthropometrics

Not described

Location

UK, The Netherlands, France, Germany and Belgium

Summary of Results:

Key Findings

Is the product used as predicted or recommended?

Market research was conducted for 2,000 households over 12 or 13 weeks
The majority of all people purchasing the product were from one- or two-person households
If households who purchased the product contained children, the children were more than five years old
For the UK, Netherlands and Germany most purchasers and regular purchasers (83-91% and 87-95%, respectively) were over age 45. The results for Belgium and France found that all purchasers and regular purchasers were over age 50.
Median daily intake per household ranged from 3 grams per day to 12 grams per day Regular users consumed a median intake of 15 grams per day to 18 grams per day per household
The upper level of intake for all users was 21 grams per day to 33 grams per day
The upper level of intake for regular product users ranged from 27 grams per day to 45 grams per day.

Are known effects as predicted? Does the item produce unexpected health effects?

84,000 calls were received in the first year at the customer care phone number, most of which occurred during the first seven months. 1,673 were complaints, 227 of which were related to health issues. Further assessment of each call resulted in only 145 calls having a causal relationship between product use and symptom onset could not be excluded.
Most calls were requests for more information, product availability, testimonials and general questions
Health-related calls were all self-diagnosed, and no health care practitioners made calls on their patients' behalf. More than 80% of the health-related calls were related to gastrointestinal issues (diarrhea or constipation) and skin conditions (urticaria, rashes, pimples and itching). Other health-related calls were regarding self-reported, and generally single occurrence, tingling, headache, shortness of breath, dizziness, rapid heart rate and joint pain.

Consumer contacts in the European Union

	Period 1 (August 2000-March 2001)	Period 2 (April 2001-August 2001)	Total (August 2000- August 2001)
Total calls	53,366	30,302	83,668
Complaints	1,167	505	1,673
Health-related	146	81	227
Red	0	0	0
Orange	74	34	108
Yellow	14	2	16
Green	38	33	71
Not enough information	13	8	21
Irrelevant	7	4	11

Health-related calls by body area

Body area affected	Number of calls
Gastrointestinal	76
Skin	40
Genito-urinary	2
Central nervous system	1
Cardiovascular	3
Cardiovascular	3
Muscle/skeletal	3
Other	27
Total	152*

*Seven calls were related to more than one category, thus the total 152 calls.

Author Conclusion:

Spread intake was less than assumed based on the initial assessment but was not unexpected
Intake of 20 grams of spread daily is not likely to lead to significantly biological reduction of serum carotenoids
Consumer awareness of a new food product may influence associating symptoms or illness with intake of the product
No clear patterns of side effects of the product were observed. Although self-reported side effects were claimed, no adverse health events were found to be caused by intake of the spread.

Funding Source:

Industry:

Unilever

Food Company:

Reviewer Comments:

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)	???
	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?	Yes
	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?	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?	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.)	Yes
	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?	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
	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?	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?	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?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	???
	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?		N/A
	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?	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