Umeå University, Department of Clinical Sciences
Umeå, 90185, Sweden
NCT Number: NCT05442281
Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.
With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.
In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.
The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.
This study is active but is not currently recruiting participants.
4 month–8 month
All sexes
Observational
Umeå, 90185, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months of age
Blood
Time frame: 12 months of age
measured weight at 12 mo using a device for measuring weight
Time frame: 3 years of age
Scale for cognitive development. Expected mean 100. Higher scores equals better cognitive development.
Time frame: 3 years of age
FMI, measured by DEXA-scan
Time frame: 3 years of age
LMI, measured by DEXA-scan
Time frame: at 12 months of age
3 day food diary
Time frame: at 12 months of age
3 day food diary
Time frame: at 12 months of age
3 day food diary
Time frame: throughout study
3 day food diary
Time frame: 6, 12, 24, 36 months
Serum sample
Time frame: 6, 12, 24, 36 months
Serum sample
Time frame: 6, 12, 24, 36 months
Serum sample
Time frame: 6, 12, 24, 36 months
Serum sample
Time frame: 6, 12, 24, 36 months
serum sample
Time frame: 12 months of age
Serum sample
Time frame: 12 months of age
serum sample
Time frame: 12 months of age
Blood sample
Time frame: 12 months of age
Serum sample
Time frame: 12 months of age
measured length at 12 mo using measuring tool for children
Time frame: 12 months of age
measured at 12 mo using measuring tool for children
Umeå University
Other
Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment
Acronym: VHS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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