Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 3 - 5 |
| Updated: | 8/5/2018 |
| Start Date: | July 10, 2018 |
| End Date: | September 2020 |
Response of the Gut Microbiome and Circulating Metabolome to Diet Intervention in Young Children: Ancillary Study to the Keeping Ideal Cardiovascular Health Family Intervention Trial (KIDFIT)
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).
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).
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 (n=140). 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.
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 (n=140). 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.
Inclusion Criteria:
- participating in KIDFIT (NCT03405246)
Exclusion Criteria:
- none
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