Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design

Navas‐Carretero, Santiago; Martinez, J Alfredo

doi:10.3109/09637486.2015.1025720

Cited by 9 publications

(8 citation statements)

References 21 publications

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“…Obesity in the pediatric population of Romania may be related to the country's communist period, which later favored the overexposure to fast food, fizzy drinks, and sweets as well as high consumption of salt and food additives (19,20). Unbalanced and highly caloric food has been preferred to healthy food (21,22).…”

Section: Discussionmentioning

confidence: 99%

Dietary habits and lifestyle in school-aged children from Bucharest, Romania

Stoian¹,

Andronache²,

Hainăroşie³

et al. 2018

JMMS

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Background. This study evaluated the difference between boys and girls in terms of nutritional status, lifestyle, and dietary habits during school life. Materials and Methods. A descriptive and observational study was conducted in 2016, in which 251 children, aged 7-17, from 3 elementary schools and a high school in Bucharest, Romania, were evaluated. A questionnaire was used to assess food behavior, eating, and lifestyle habits. Results. Boys had a significantly higher waist circumference (71.18±9) than girls (67.46±9.91) (p=0.004). Thus 27% of boys were overweight or obese compared with only 22% of the girls. Differences were also seen between the two groups in terms of main meals and snacks and following a rhythm of meals: a statistically significant percentage of girls (36.3%) skip breakfast, while most boys (63.8%) take a food package to school. A total of 23.8% of the boys and 24% of the girls state that they eat while sitting in front of the computer or TV. Conclusions. We found that boys are more overweight or obese than girls. Obesity in the pediatric population of Romania could be explained by the country's emergence from communism 25 years ago, pattern typical of all Eastern European countries and which currently involve an overexposure of people to fast food, fizzy drinks and sweets, as well as to a high consumption of salt and food additives. Unbalanced and highly caloric food had been preferable to healthy food in the last period. Leisure time is rather spent in front of the TV, tablet, detrimental to rational physical exercise, recreational sports or hiking. The family environment is very important and all our actions should be focused on continuous education about the risks of unhealthy food and a sedentary lifestyle.

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Section: Discussionmentioning

confidence: 99%

Dietary habits and lifestyle in school-aged children from Bucharest, Romania

Stoian¹,

Andronache²,

Hainăroşie³

et al. 2018

JMMS

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“…In addition, several experimental data clearly demonstrate the hormetic effects of phytochemicals by inducing cellular stress resistance mechanisms [ 1 , 8 ]. In designing human intervention studies to provide high-quality evidence for their health benefits, the following factors have to be considered: 1) the phytochemicals need to be sufficiently characterised, as well as its optimal physiologic dose, 2) the characteristics of targeted populations including their nutritional status, health condition, and genetic background have to be taken into account, 3) clinically relevant, sensitive, reproducible, and feasible endpoints have to be identified, 4) length of the intervention have to be commonly agreed [ 24 – 26 ]. However, even though experimental data have not always translated to a definitive clinical effect, the antioxidant and anti-inflammatory properties of phytochemicals have been widely accepted.…”

Section: Discussionmentioning

confidence: 99%

Nutrigerontology: a key for achieving successful ageing and longevity

et al. 2016

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During the last two centuries the average lifespan has increased at a rate of approximately 3 months/year in both sexes, hence oldest old people are becoming the population with the fastest growth in Western World. Although the average life expectancy is increasing dramatically, the healthy lifespan is not going at the same pace. This underscores the importance of studies on the prevention of age-related diseases, in order to satisfactorily decrease the medical, economic and social problems associated to advancing age, related to an increased number of individuals not autonomous and affected by invalidating pathologies. In particular, data from experimental studies in model organisms have consistently shown that nutrient signalling pathways are involved in longevity, affecting the prevalence of age-related loss of function, including age-related diseases. Accordingly, nutrigerontology is defined as the scientific discipline that studies the impact of nutrients, foods, macronutrient ratios, and diets on lifespan, ageing process, and age-related diseases. To discuss the potential relevance of this new science in the attainment of successful ageing and longevity, three original studies performed in Sicily with local foods and two reviews have been assembled in this series. Data clearly demonstrate the positive effects of nutraceuticals, functional foods and Mediterranean Diet on several biological parameters. In fact, they could represent a prevention for many age-related diseases, and, although not a solution for this social plague, at least a remedy to alleviate it. Thus, the possibility to create a dietary pattern, based on the combined strategy of the use of both nutraceuticals and functional foods should permit to create a new therapeutic strategy, based not only on a specific bioactive molecule or on a specific food but on a integrated approach that, starting from the local dietary habits, can be led to a “nutrafunctional diet” applicable worldwide.

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“…As in the case of pharmaceuticals, the only scientific methodology able to establish such causal relationships are RCTs (Navas-Carretero and Martinez 2015). This turns the use of this methodology into a practical requirement for data generation for being able to obtain authorization of a health claim in Europe.…”

Section: Case 3: the “Best Method” In Benefit Assessment Is The Most ...mentioning

confidence: 99%

Rationality in Context: Regulatory Science and the Best Scientific Method

Todt

Luján

2021

Science, Technology, & Human Values

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Is there such a thing as a “best scientific methodology” in regulatory (decision-oriented) science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented (academic) science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as to methodological choice. What goes by the most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational.

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Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design

Cited by 9 publications

References 21 publications

Dietary habits and lifestyle in school-aged children from Bucharest, Romania

Dietary habits and lifestyle in school-aged children from Bucharest, Romania

Nutrigerontology: a key for achieving successful ageing and longevity

Rationality in Context: Regulatory Science and the Best Scientific Method

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