Nutritional and Metabolic Status of Vegetarian and Omnivorous Portuguese Adults

NCT05408962 | Unknown

• 1 other identifier: VeggieNutri_2022
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Vegetarian; Diet, Vegan; Nutritional Status; Metabolic Profile

Keywords

Vegetarian; Vegan; Diet quality; Metabolic profile; Nutritional status; Metabolic outcomes; Sustainable diets; Sustainability

Outcome Measures

Primary Outcomes (2)

• Diet Quality Index for each regimen

  Diet quality will be assessed through a Diet Quality Index (DQI) created by VeggieNutri's workteam. DQI is a tool that quantifies the quality of an individual's intake, scoring their food intake, assessed buy a Food Frequency Questionnaire (FFQ). Each question regarding their food intake will be scored from 0 to 10 points, depending on how close they are to complying with guidelines and recommendations (the closer to complying, the highest the scoring and the farthest, the lower the scoring).

  7 months

• Nutritional inadequacy prevalences

  Nutritional inadequacy prevalences will be calculated based on DQI scores and also on reference values for micronutrients in blood or urine.

  11 months

Secondary Outcomes (5)

• Levels of vitamins B12, B6, B9 and D, homocysteine, iron, selenium, calcium, zinc and magnesium

  6 months

• Waist circunference and percentage of body fat

  6 months

• Fasting glycaemia and HOMA-IR

  6 months

• Blood LDL, HDL and total cholesterol and triglycerides

  6 months

• Urinary iodine concentration

  6 months

Study Arms (3)

OMNI - omnivorous

Healthy omnivorous adults with ages between 18 and 65 years and having the reported dietary regimen for at least 1 year, free from any chronic condition such as metabolic, digestive, renal, haematological, endocrine or oncological diseases and presenting no food intolerances or eating disorders.

Other: Blood and urine collection, anthropometric analysis and answering to questionnaires

LOV - lacto-ovovegetarians

Healthy lacto-ovovegetarians adults with ages between 18 and 65 years and having the reported dietary regimen for at least 1 year, free from any chronic condition such as metabolic, digestive, renal, haematological, endocrine or oncological diseases and presenting no food intolerances or eating disorders.

Other: Blood and urine collection, anthropometric analysis and answering to questionnaires

VEG - vegan

Healthy vegan adults with ages between 18 and 65 years and having the reported dietary regimen for at least 1 year, free from any chronic condition such as metabolic, digestive, renal, haematological, endocrine or oncological diseases and presenting no food intolerances or eating disorders.

Other: Blood and urine collection, anthropometric analysis and answering to questionnaires

Interventions

Blood and urine collection, anthropometric analysis and answering to questionnaires OTHER

During the visit to the recruitment center, participants will sign an informed consent. They will have to be in fasting condition for blood and urine collection. In addition they will 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.

LOV - lacto-ovovegetarians; OMNI - omnivorous; VEG - vegan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (1)

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be used to measure major metabolic outcomes. Urine samples will be used for oligoelement quantification (eg iodine).

MeSH Terms

Interventions

Blood Specimen Collection; Urine Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elisa Keating, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Keating, PhD

CONTACT

(+351) 225513624; keating@med.up.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 7, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

PT (1)