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Table 1 Primary and secondary outcomes and adherence and background factors collected the Optimized complementary feeding study

From: Study protocol: optimized complementary feeding study (OTIS): a randomized controlled trial of the impact of a protein-reduced complementary diet based on Nordic foods

Primary outcomes
 Body composition Anthropometry (body weight, body length, head circumference) Fat and fat-free mass (deuterium-labelled water)
 Biomarkers of metabolic function P-insulin, P-glucose, P-IGF-1, P-lipids and lipoproteins, P-fatty acids and erythrocyte membrane fatty acids including LCPUFAs (DHA, EPA, ARA), metabolomics (plasma and urine) and lipidomics (plasma), markers of oxidatative capacity, hsCRP
 Faecal microbiota composition Obesity-promoting microflora
 Blood pressure  
Secondary outcomes, adherence and background factors
 Dietary intake  
 Biomarkers of adherence Haemoglobin, iron status, P-urea, vitamins C, A, E, carotenoids, folic acid, C15 and C17 fatty acids
 Food acceptance Videotaped test meal
 Eating behaviour CEBQ, CFQ, COC, bitter taste gene TAS2R38
 Temperament BBQ and TBQ
 Cognitive development Attention free play and ASQ
 Allergy and atopic manifestations  
 Symptoms registration  
 Background factors Child’s neonatal history, early nutrition, past and present illnesses, family composition, mother’s pregnancy history, education, employment, smoking habits, history of chronic illnesses, father’s education, employment, smoking habits, history of chronic illnesses