Controversies about population, clinical or basic research studies

Nutr Hosp. 2015;31(Supl. 3):15-21
ISSN 0212-1611 • CODEN NUHOEQ
S.V.R. 318
Controversies about population, clinical or basic research studies related
with food, nutrition, physical activity and lifestyle
Javier Aranceta Bartrina1,2,8, Carmen Pérez Rodrigo3, Goiuri Alberdi Aresti4, Gregorio Varela Moreiras5,6
and Lluis Serra-Majem2,7,8
Departamento de Medicina Preventiva y Salud Pública. Universidad de Navarra, Pamplona, Spain. 2Fundación para la
Investigación Nutricional (FIN), Parc Científic de Barcelona, Barcelona, Spain. 3Fundación FIDEC. Bilbao, Spain. 4School of
Medical Sciences, University of Aberdeen, Institute of Medical Sciences, Aberdeen, Scotland, UK. 5Department of Pharmaceutical
and Health Sciences, Faculty of Pharmacy, CEU San Pablo University; Madrid, Spain. 6Spanish Nutrition Foundation (FEN),
Madrid, Spain. 7Instituto de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Las Palmas,
Spain. 8CiberOBN, Instituto de Salud Carlos III, Madrid, Spain.
1
Abstract
Nutritional studies including food and beverage consumption assessment are needed for different purposes
in the field of nutrition, food supply monitoring, toxicology or in the context of intervention strategies that include changes in eating behaviors. Different methods have
been used, each with strengths, weaknesses, biases and
limitations that must be considered when choosing the
most appropriate in each case. The development of new
technologies offers exciting developments to improve the
validity and accuracy of these methods, as well as their
efficiency and commodity. The characteristics of the individuals under study, its environment and the resources
available should be considered as well.
(Nutr Hosp 2015;31(Supl. 3):15-21)
DOI:10.3305/nh.2015.31.sup3.8746
Key words: Food consumption assessment. Validity. Precision. New technologies.
CONTROVERSIAS SOBRE LOS ESTUDIOS
POBLACIONALES, CLÍNICOS O DE
INVESTIGACIÓN BÁSICA RELACIONADOS
CON LA ALIMENTACIÓN, NUTRICIÓN,
ACTIVIDAD FÍSICA Y ESTILOS DE VIDA
Resumen
Los estudios nutricionales que incluyen análisis del
consumo de alimentos y bebidas son necesarios con diferentes finalidades de interés nutricional, alimentario, toxicológico o en el contexto de estrategias de intervención
que incluyen la modificación de conductas alimentarias.
Se han venido utilizando diferentes métodos, cada uno
con ventajas, inconvenientes, sesgos y limitaciones que
deben considerarse al elegir el más adecuado en cada
caso. El desarrollo de las nuevas tecnologías ofrece avances interesantes para mejorar la validez y precisión de
estos métodos, así como su rápidez y eficiencia. También
debe tenerse en cuenta las características de los individuos objeto del estudio, su entorno así como los recursos
disponibles.
(Nutr Hosp 2015;31(Supl. 3):15-21)
DOI:10.3305/nh.2015.31.sup3.8746
Palabras clave: Consumo alimentario. Evaluación. Validez. Precisión. Nuevas tecnologías.
Correspondence: Javier Aranceta.
Community Nutrition
PO Box 5199. 48080 Bilbao (Spain).
E-mail: jaranceta@unav.es
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Abbreviations
AECOSAN: Agencia Española de Consumo, Seguridad Alimentaria y Nutrición.
AMPM: Automated Multiple Pass Method.
EC: European Community.
EFSA: European Food Safety Authority.
FAO: Food and Agriculture Organization of the
United Nations.
FIVR: Food Intake and Voice Recognizer.
MAGRAMA: Ministerio de Agricultura, Alimentación y Medio Ambiente.
TADA: Technology Assisted Dietary Assessment.
ANIBES: Antropometría, Ingesta, y Balance Energético en España.
ENPE: Estado Nutricional de la Población Española.
ENIDE: Encuesta Nacional de Ingesta Dietética.
PREDIMED. Prevención con Dieta Mediterránea.
PERSEO: Programa piloto Escolar de Referencia
para la Salud y el Ejercicio contra la Obesidad.
NHANES: National Health and Nutrition Examination Survey.
Introduction
Health status is influenced by different genetic,
individual and environmental factors that in variable
proportionality interact with well-being, the morbidity/mortality and the vital projection towards future
generations.
Under this assumption, knowledge and analysis of
food habits, physical activity, energy balance and other
lifestyle factors can be of great help in nutritional epidemiology studies and in processes of health-planning,
development of dietary recommendations or when
dealing out health plans.
Regarding these studies and their findings, doubts
and controversies arise depending on the complexity
and diversity of the methodologies to be used, the criteria employed to set cut-off points, or the normality
ranges of different variables; or, more frequently the
doubts are concerned with the insufficient quality data
obtained during field-work interviews.
Most of the information collected in such studies
belongs to the intimate personal domain of people,
such as their eating habits, their shopping, cooking or
eating manners, time-schedules, daily life style and
other personal characteristics1. Sometimes methodological aspects might be placed into question, such as the
tools used for nutritional assessment or other aspects
related with the variability of intake, but in most cases,
there are two important blocks of uncertainty:
–– Incomplete or biased information on dietary intake, amount of physical activity or other lifestyle
factors. We often think on memory lapses, but
there are reasons about masking the reality, due
to an urge for approval of habits and social desi-
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rability, or even due to saturation induced by too
long and poorly motivating interviews.
–– One of the aspects that are more difficult to assess
is related to physical activity: time spent, type or
intensity. The use of validated questionnaires is
only a first estimate, and instrumental aids such
as accelerometers are very expensive to be used
in large scale studies and require specialized personnel for proper interpretation.
In this regard, one of the characteristics of most
population studies is a large percentage of energy
miss-reporters, but also for some specific food groups,
nutrients, or self-reported physical activity and a lack
of specification of the energy balance of the individuals and groups under study2.
With these limitations seems very risky to use the
results obtained in a study to modify sustainably the
current diet, to generate recommendations and to plan
actions towards public health.
Based on this strategic approach it seems necessary
to encourage the implementation of representative surveys of food use reality and its determinants, where
the evaluation of physical activity, culinary habits and
individual sensitivity on sustainable production, ecological and emotional balances, are blocks of variables
considered for an operational analysis.
Purpose and interest of food consumption studies
In general, the studies related to food and beverage
intake have multiple streams of application, ranging
from institutional commitment for monitoring food intake or shopping basket to a more commercial interests
linked with marketing strategies and market analysis1.
Some of these areas of application are summarized
in the following sections (table I):
1.- Nutritional interest
–– Estimation of the adequacy of the food and nutrient intake to the Recommended Dietary Intake
and Dietary Guidelines in each region or country. For example, the recent studies carried out
in Spain such as the ANIBES study3, the ENPE
project4 or the ENIDE study5.
–– Evaluation of the relationship between diet-nutritional status-health: nutritional epidemiology. In
this section we consider for example the recent
contributions of the PREDIMED study in Spain6.
–– Assessment Tool for evaluating nutrition education programs, nutritional interventions and food
fortification programs, for instance, some of the
phases of the PERSEO project7.
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Table I
Aims and uses of food consumption studies
Food and Nutrition Plans
Food supply and distribution.
Examples:
Food Balance Sheets
Household Budget Surveys
Nutrition interest
Nutrient inadequacy.
Nutrition and Health Surveys:
Regional surveys (Catalonia, Basque
Country, Canary Islands, Madrid, Valencian Region, Andalusia…)
Toxicological aspects of food supply
Total Diet studies
EU Menu
National surveys
ENIDE (Spain), NHANES (USA), Germany, Austria, Finland, France, Ireland,
Netherlands, United Kingdom, Australia,
New Zealand…
Food production and distribution.
Examples:
Ministry of Agriculture surveillance
Epidemiological research
about diet- nutrition- health status.
Example: PREDIMED…
Food regulation, food fortification
and nutrition education
Evaluation of nutrition intervention
programs, policies.and guidelines
2.- Food and Nutrition Planning
–– Analysis of the production and availability of
food in a region or country (FAO Food Balance
Sheets)8.
–– Analysis of supply and distribution of food and
beverages (Household Budget Surveys9, MAGRAMA10,11 or MERCASA12 surveys in Spain).
–– Food and Nutrition Surveillance Programs (AECOSAN)13.
–– Food regulation, food fortification and nutritional
education projects as some of those led by AECOSAN on salt content of some foods.
3.- Toxicological aspects of food supply
–– Total Diet Studies to determine trace elements
and contaminants in food. Several regions have
developed such studies, as also did AECOSAN
recently14.
–– EU Menu, project coordinated by the European
Food Safety Agency (EFSA) aiming to promote
the collection of data on food consumption in European countries with standardized procedures,
in order to assess the exposure and risk analysis
more accurately and efficiently. It will collect
data about the European population menu between 2012 and 2017.
Some common concerns in nutritional studies
There are many elements to consider in all population studies, from the selection of the sample to the
interpretation of the results, but one of the limiting factors is related with the validity and reliability of the selected methodology for data collection on food intake.
Table II summarizes frequent issues and controversies
related to food consumption and nutrition surveys.
From the available methods and their variants, the
procedure chosen usually depends on the purpose,
budget, resources and characteristics of the sample
group. In all cases, our ultimate goal is to determine
the usual intake of the individuals and groups under
study15.
Knowledge of the usual and real intake is a demanding goal. The application of different complementary supportive methods based on food records will
be required, such as, one or more 24-hour recalls or
the Automated Multiple Pass Method (AMPM). The
latter one is a computerized method used to systematically collect the reminders of food eaten in 24 hours
by telephone or face-to-face interview. Other methods
include food frequency questionnaires and even diet
history questionnaires. Based on the information collected, appropriate statistical analysis will help to model usual intake and provide estimates closer to real
intake.
Data collection is key in this process. Planning the
adequate strategy for data collection is as important as
choosing the appropriate method and protocol, preparing the suitable arrangements to involve trained and
qualified personnel. They can motivate respondents to
collaborate and get them to contribute as best the quality and complete information as possible.
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Table II
Issues and controversies in food and nutrition studies
Issue
Controversy
Validity
Cost-effectiveness
Estimation of usual intake
Appropriate method according to aims and resources
Harmonization – comparability of data
Energy balance
Underreporting- Overreporting
Portion size
Food models and replicas
Photograph models
New technologies
Special foods and additions
Bread
Salt
Water and beverages
Fats and oils
Supplements
Respondent burden
Influence eating behavior
Response rate
Special population groups
Cognitive ability
Surrogate response
Energy and nutrient intake estimates
Food composition databases
Suitable software- platforms
Biomarkers
Energy and nutrient intake
Physical activity
Omics
Physical activity
Questionnaires
Accelerometry
New technologies
Data analysis
Response rate
Bias and adjustments
This work requires the support of validated tools for
the interpretation of weights and portion sizes as well as
a appropriate use of new technologies as means to save
this information in a quick, precise and easy manner.
This is undoubtedly one of the key points of nutritional
studies.
EFSA work-teams have suggested a methodological
approach to make a consistent data collection and nutritional assessment in order to obtain reliable data and
hence be able to compare the data collected in surveys
conducted in different countries as well as provide the
possibility to combine efforts and data from different
countries in the European Community (EC)16,17.
Portion size models and dietary intake assessment
As mentioned earlier, the portion size and weight
estimations of food intake are limiting factors in nutritional studies. We are interested in gathering all information on the consumption of food and drinks in a
given period of time, but also, we may want to assess
the portion of sizes and weights of foods consumed
and food ingredients.
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Different kinds of food models have been used in
food and nutrition surveys since the Nutrition Survey
of Canada in 1974. In that survey, sizes and thicknesses of cardboard, calibrated containers and other gadgets were used as food models to estimate the portion
sizes of foods consumed. Other procedures include
food replicas, household measures (plates, spoons,
glasses, cups...) and even modeling with fingers and
hands. Currently, photographic models and technology based aids are the most widely used resources18.
Photographic models are suitable for being specifically designed for each study, considering four or more
volumetric references for food or food group19-23. The
description of the average servings consumed as small,
medium, large or very large can also be useful, depending on the level of the information required.
These days, web pages, laptops, tablets or mobile
phones with specific applications are frequently used
for this purpose. Sometimes, images are recorded to
display the choice of food in catering or during the
process of buying in small shops or supermarkets or
even to support food records21-28.
Technology Assisted Dietary Assessment (TADA)
system is one of such new technological applications,
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which involves capturing photos with the mobile before and after food consumption. These photos are
tagged with supporting details to estimate the portion
size and subsequent automatic analysis from a link to a
database of food composition analysis29.
The Food Intake and Voice Recognizer (FIVR) system allows us to capture images with the mobile and
simultaneously record comments about the prepared
dishes to be consumed. The information is processed
with the estimation of food portion sizes and volumes.
The end result is a dietary study with automated nutritional assessment30.
The sensor system e-button, for ubiquitous evaluation,
allows image capturing and logging of data for a day or a
set period. This method is based on the use of a device with
sensors and a recording camera that allows for a real-time
collection of information from environmental factors, food
shopping, food intake, cooking techniques used, physical
activity, leisure time activities, and consumption of drinks
or other substances. It is a process of great interest in the
future of telemedicine and health research31.
the number of users in each family. Information on the
use of extra salt at the table and/or contribution of salt
marked with lithium. We can draw on 24 hour urine
collection for the determination of sodium and particularly, we can draw on a good food composition table
or on a duplicate portion analysis system.
Main difficulties in estimating dietary intake
Bread
Dietary assessment is a complex procedure. All
foods, fresh or processed, need a special attention to
get a more precise picture and avoid the leak of any
details to the overall assessment. However, there are
some elements of the diet are particularly difficult for
accurate quantification.
In some situations, bread is a food of difficult characterization. We will need to know the sizes and weights of the most used breads in each region, along with
the weight and size of the loaves and alike. Photographic models, home measures and the usual shopping
will help in quantifying bread consumption.
Water and beverages
Other critical variables
The estimated consumption of water and other
drinks require special attention and the use of specific
validated questionnaires. Many people have trouble
remembering their water and overall beverages intake
and its variability further complicates the assessment
of the usual intake. Use of biomarkers and urine output
are recommended.
Along with the complexity of assessing the diet as a
whole and some foods or products in particular, various
challenges arise regarding the relationship between the
respondent and the interviewer throughout the fieldwork process. This issue will be discussed with particular thoroughness in some sections of this monograph.
This is about getting a good rate of valid responses on
a well selected theoretical sample. Adapt the whole dynamic of the process to encourage the participation and
collaboration of respondents and nonetheless conduct
an adequate analysis of the nonresponse rate.
Other added peculiar features should be noted in
some groups such as the elderly, children, disabled,
homeless, immigrants or people affected by illness,
etc. Also in cases of surrogate responses.
Some studies have important limitations based on
low response rates, important under-response subgroups and the use of low quality or difficult to compare food composition tables.
Some biases are related with the lack of quality information on nutritional supplements or dietetic products intake. Also bias can be related with the use of
just few days for intake analysis or periods that do not
allow integrating seasonal or monthly variability.
Alcoholic beverages
The assessment of alcohol intake in alcoholic beverages users requires a thorough interview about this
particular product, starting from the time of getting
up to bedtime and even at night-times. This section
should be completed at the end of the interview with a
sensible approach and empathy.
Salt intake
Assessment of salt and total sodium intake is a difficult challenge. Information can be derived from the
buying and spending of salt in a given time period by
Intake of oil and other added fats
Quantification of oil consumption individually or in
a group have varying degrees of difficulty depending
on culinary techniques, added oil, type of oil, or the
ratio between oil availability and intake, among others.
A homogenous criteria needs to be placed for allocating oil consumption depending the type of dish and
food volume and wherever possible it should be accompanied by the use of biomarkers.
For fat spreads the recipe will be used, home servings or quantities allocated according to the size of
the receiving surface.
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Instrumental assessment: anthropometry and
physical activity
Some nutritional studies and almost all the studies
aimed at assessing nutritional status incorporate a relatively extensive section on anthropometric measurements. This section requires a large technical training,
approved/homologated instrumentation, calibration
and daily quality controls. The preceding work before a study begins will allow achieving a high level of
training in making measurements, along with the decision of the cut-off points and the reference values to
be used.
As explained earlier, a key points related to the investigation of physical activity and caloric expenditure
of each study participant. The use of validated questionnaires will be aided by incorporating modern instruments and new technologies such as specific applications in connection with accelerometers, pedometers
and other technical utilities32.
The relevance of incorporating haematological and
biochemical indicators, other biological tests or genetic determinants will be discussed by the research
team depending on the objectives of the project and
the characteristics of the study group. Finally, Ethics
Committees will be an added guarantee of balance in
our overall proposals.
Other lifestyles
In this preliminary review on the various factors to
consider in the development of population studies on
nutritional status, we cannot forget to include smoking, alcohol, medicaments and other drugs, along
with accurate indicators of mental health/well-being
and quality of life.
From the modelled framework of the Mediterranean
Diet we will not forget the chronobiological aspects,
time and environment dedicated to each meal, sustainability criteria, characteristics of food production, the
balance of remains, leftovers and other anthropological variables related to diet.
All of them are factors related with and determinants
of dietary habits and health status. These data, in varying degrees, will be of great use for our future proposals of intervention initiatives and nutrition education.
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