Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)
Condition: Gastrointestinal Microbiome; Metabolome; Pediatric Obesity; Dietary Approaches to Stop Hypertension
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age
      children, born to overweight or obese mothers, respond to a healthy DASH diet intervention
      with better cardiovascular health.

      This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in
      the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH
      diet intervention, and how the microbiome and metabolome relate to the children's
      cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will
      modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome
      will be related to each other, and (3) the microbiome and metabolome will be associated with
      the children's cardiovascular health profiles (things like weight, body fat, blood pressure,
      and cholesterol).
    

Detailed description: 
      The majority of deaths from cardiovascular disease (CVD) in US adults ages 25-54 years are
      associated with suboptimal diet. While diet is an important target of CVD prevention efforts
      in adults, intervention on the childhood diet may be more effective. Animal data suggest that
      early-life diet has the unique potential to modulate biological systems and durably program a
      child's biology for long-term health or disease. The objective of this study is to define the
      molecular effects of a dietary pattern intervention on the gut microbiome and circulating
      metabolome in young children. This objective will be attained through an ancillary study to
      KIDFIT, a clinical trial that tests the effects of a 12-month Dietary Approaches to Stop
      Hypertension (DASH) diet intervention on adiposity and other cardiovascular health (CVH)
      metrics (e.g., blood pressure, lipids) in 3- to 5-year old children. Using additional
      participant samples, deep phenotyping and advanced bioinformatics, the ancillary study will
      address three specific aims. First, it will test the effect of the DASH diet intervention on
      the gut microbiome, including abundances of microbial taxa, communities, and
      metabolism-related genes and transcripts. Second, it will define the associations of diet and
      the gut microbiome with the circulating metabolome. Using targeted and nontargeted
      metabolomics approaches, blood metabolites, metabolite networks, and metabolic pathways will
      be evaluated. Finally, in an exploratory fashion, it will probe pathways linking the diet
      intervention with subsequent adiposity and CVH metrics, through the gut microbiome and serum
      metabolome. The expected outcome is a preliminary model of how the DASH diet alters the gut
      microbiome and circulating metabolome in young children, and how these alterations relate to
      short-term CVH outcomes.
    

Intervention name(s): KIDFIT Healthy; KIDFIT Safe
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The KIDFIT Healthy intervention promotes the DASH diet, physical activity, limited screen time, and adequate sleep, through a combination of traditional in-person and electronic participant contacts. See NCT03405246 for details.; The KIDFIT Safe active control provides electronic material about safe home environments and activities (e.g., sun screen, choking hazards, pet safety) for children. See NCT03405246 for details.
Other intervention name(s): Intervention Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention