Ingestion of micronutrient fortified breakfast cereal has no influence on immune function in healthy children: A randomized controlled trial

BACKGROUND: This study investigated the influence of 2-months ingestion of an "immune" nutrient fortified breakfast cereal on immune function and upper respiratory tract infection (URTI) in healthy children during the winter season. METHODS: Subjects included 73 children (N = 42 males, N = 31 females) ranging in age from 7 to 13 years (mean ± SD age, 9.9 ± 1.7 years), and 65 completed all phases of the study. Subjects were randomized to one of three groups--low, moderate, or high fortification--with breakfast cereals administered in double blinded fashion. The "medium" fortified cereal contained B-complex vitamins, vitamins A and C, iron, zinc, and calcium, with the addition of vitamin E and higher amounts of vitamins A and C, and zinc in the "high" group. Immune measures included delayed-typed hypersensitivity, global IgG antibody response over four weeks to pneumococcal vaccination, salivary IgA concentration, natural killer cell activity, and granulocyte phagocytosis and oxidative burst activity. Subjects under parental supervision filled in a daily log using URTI symptoms codes. RESULTS: Subjects ingested 3337 ± 851 g cereal during the 2-month study, which represented 14% of total diet energy intake and 20-85% of selected vitamins and minerals. Despite significant increases in nutrient intake, URTI rates and pre- to- post-study changes in all immune function measures did not differ between groups. CONCLUSIONS: Data from this study indicate that ingestion of breakfast cereal fortified with a micronutrient blend for two winter months by healthy, growing children does not significantly influence biomarkers for immune function or URTI rates.