NUTRISHIELD will support the execution of three validation studies in clinical settings:

Trial I

Personalised nutrition of young individuals (8-18 years of age), with obesity and/or type 2 diabetes, aiming at ameliorating their health condition.

Objectives:

a) To evaluate the effectiveness of a “personalized” diet to young children with obesity or type 2 diabetes, versus the non-personalized approach.

b) Assessment of the effectiveness of an intensive Personalized Dietary intervention, encompassing genetic predisposition, biochemical markers and phenotypic information in a) children with obesity and type 2 diabetes (Intervention Group I) and b) obesity without type 2 diabetes (Intervention Group II), over the non-personalized approach (current lifestyle intervention) in children with obesity without type 2 diabetes (Control Group).

c) Assessment of the effectiveness of the suggested intervention in altering the concentration of novel biomarkers measured in breath, urine or faeces in the two intervention groups. Identification of possible links with obesity/ type 2 diabetes onset/or progression.

d) Assessment of the effectiveness of the suggested intervention in altering microbiome in the two Intervention groups vs. the Control group. Identification of possible links with obesity/ type 2 diabetes onset/or progression.

e) Cost-effectiveness analysis of the suggested dietary intervention for children with obesity or type 2 diabetes vs. other conventional approach. A short and concise description of the research methodology of the “NUTRISHIELD” clinical trial is presented, based on the CONsolidated Standards of Reporting Trials (CONSORT) Updated checklist (2017) for non-pharmacologic treatment interventions to refer to the most important methodological issues that should be addressed

Trial II

Personalised nutrition of lactating mothers, aiming at augmenting the nutritional value of human milk (HM). This will focus on prematurely born infants, which have increased needs in supplied nutrients.

Objective: To assess the impact of the mother’s diet on milk composition and growth and health status of preterm infants. Study design: The proposed study is a prospective observational cohort study (longitudinal, descriptive) to assess the relationship between maternal diet, nutrient levels in HM and genotype and microtype as well as metabolic response of the preterm infant. 

Trial III

Personalised nutrition of young individuals (8-10 years of age), aiming at avoiding the development of cognitive decline. This will be linked to an ongoing trial performed by Donders.

Objective: To assess whether nutritional status can affect the outcome of spatial cognition training in the brain. Differences in brain activation patterns (fMRI) pre- and post-training will be related to nutritional status, as measured by a composite score of the Dutch healthy diet index (i.e. a food frequency questionnaire assessing adherence to the Dutch healthy diet guidelines) and visceral adipose tissue quantified by abdominal MRI.