Clinical trial NCT05408962: Nutritional and Metabolic Status of Vegetarian and Omnivorous Portuguese Adults
Official title: VeggieNutri - Nutritional and Metabolic Status of Vegetarian and Omnivorous Portuguese Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diet, Vegetarian
Diet, Vegan
Nutritional Status
Metabolic Profile
Keywords: Vegetarian
Vegan
Diet quality
Metabolic profile
Nutritional status
Metabolic outcomes
Sustainable diets
Sustainability
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Centro de Investigação em Tecnologias e Serviços de Saúde
name: Rede de Investigação em Saúde
First posted: 2022-06-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from general population. During advertisement, people will be invited to express their interest by filling in an online form which will include information about participation eligibility (eligibility criteria explained bellow). On recruitment day eligible participants will be asked to visit the recruitment center in fasting for blood and urine collection. In addition they will sign an informed consent, answer the lifestyle questionnaire and the Food Frequency Questionnaire and will be submitted to an anthropometric analysis and evaluation of blood preassure and heart rate.

Brief summary: Vegetarian diets have low environmental footprints and are potential solutions to address climate change and the 2030 Agenda on the Sustainable Development Goals. Currently, there is no information regarding the nutritional quality of vegetarian diets in Portugal. As the trend for vegetarianism increases in the country, the aim of this study is to examine and compare nutritional and metabolic outcomes among vegetarian and non-vegetarian populations. We aim to implement a cross-sectional study that includes a total of 400 (distributed among the three diferent groups of omnivorous, lacto-ovovegatarians and vegans) healthy Portuguese adults aged 18-64 years. Blood and urine samples will be collected. Participants will be assessed for blood pressure, anthropometric parameters, micronutrient status, blood lipids, glicaemia and insuline resistance and will complete a validated food frequency questionnaire as well as a sociodemographic and lifestyle questionnaire. Dietary and nutrient analysis will be conducted to assess diet quality and nutritional inadequacies. The current proposal provides an unique opportunity to characterize and compare different population groups clustered by dietary behaviour and provide evidence that help achieve healthy and sustainable diets in Portugal.

Detailed description: Plant-based diets have been proven to be sustainable and to have low environmental impact, highlighting the importance of promoting a dietary shift towards plant-based diets, with reduction in the consumption of animal food sources. In particular, vegetarian diets can refer to vegan (VEG) diets that completely exclude all animal derived foods or to lacto-ovo vegetarians (LOV) which include eggs and milk products and have low environmental footprint compared with omnivorous dietary patterns. Vegetarian diets are gaining popularity around the world. The reasons to follow a vegetarian diet are diverse and reported to be related to religion, animal welfare, sustainability and environmental reasons, as well as health related concerns. Literature has shown several health benefits of these diets. Regarding the efficiency of vegetarianism in promoting weight loss, studies in which a lacto-ovo vegetarian or vegan diet are administered to participants show that participants with previous plant based-diets that do not fully adhere to the prescribed weight loss diet loose more weight when compared to non-vegetarians. Moreover, vegan diets have been shown to be more effective in improving body composition and insulin resistance, when compared to an omnivorous diet. Despite the above referred evidence regarding beneficial effects on weight loss, some studies find no statistical differences on weight loss promoted by vegetarians, omnivorous or Mediterranean diets. Plant-based diets were also found to improve glycaemic control and insulin sensitivity. In fact, there is evidence on vegetarians having lower fasting insulin level and higher insulin sensitivity compared with matched omnivores. Moreover, these diets are considered to have a low inflammatory load to the point of being considered as an approach to lower inflammatory markers in patients with coronary artery disease. Nevertheless, since vegetarian diets are restrictive, they may give rise to nutritionally unbalanced regimens, particularly when adopted without nutritional counselling. In fact, several studies link vegetarian diets to poor nutritional status, including micronutrient deficiency. In this context, the great rise of vegetarian habits among Portuguese population, which are reported to have quadruplicated in the last 10 years, poses important health concerns. Nevertheless, data on the nutritional status characteristics and metabolic profile of such consumers and of the nutritional adequacy of their diet are scarce, particularly comparing with people with omnivorous dietary regimens.

So, it is crucial to assess the quality of vegetarian diets in the country, identifying clear health benefits and risks from a nutritional perspective. Considering the importance of promoting environmentally sustainable diets at national level and the lack of data regarding the diet quality of vegetarian diets in the country, we propose the implementation of the first cross-sectional study in the country to investigate and compare nutritional and health parameters among vegetarian and omnivorous populations. The current proposal provides an unique opportunity to characterize and compare different population groups clustered by dietary behaviour and identify potential risks and gaps to attain health and environmental goals, such as contributing to the Portugal commitments to achieve the 2030 Agenda on the Sustainable Development Goals.

Eligibility criteria: Inclusion Criteria:

* being a healthy adult
* being aged between 18 and 65 years
* having the reported dietary regimen for at least 1 year

Exclusion Criteria:

* being free from metabolic disorders
* being free from digestive disorders
* being free from renal disorders
* being free from haematological disorders
* being free from endocrine disorders
* being free from oncological diseases
* being free from food intolerances
* being free from eating disorders

Primary outcomes:
measure: Diet Quality Index for each regimen
timeFrame: 7 months
measure: Nutritional inadequacy prevalences
timeFrame: 11 months
Secondary outcomes:
measure: Levels of vitamins B12, B6, B9 and D, homocysteine, iron, selenium, calcium, zinc and magnesium
timeFrame: 6 months
measure: Waist circunference and percentage of body fat
timeFrame: 6 months
measure: Fasting glycaemia and HOMA-IR
timeFrame: 6 months
measure: Blood LDL, HDL and total cholesterol and triglycerides
timeFrame: 6 months
measure: Urinary iodine concentration
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine (FMUP)
Study officials:
affiliation: Universidade do Porto
name: Elisa Keating, PhD
role: PRINCIPAL_INVESTIGATOR
References: