Bad Genes or Genes Behaving Badly
1 other identifier
observational
30
1 country
1
Brief Summary
A key factor in the determination of body composition over the lifecourse is fat accumulation during childhood. Periods of life associated with the greatest changes in organ development and growth, i.e. early childhood, have the most significant effect on body composition, energy balance, and metabolism. Early childhood (age 3 to 7 years) represents a critical transition for the basis of adaptability in body composition, due to the rapid growth and development that occurs. Plausibly the phenotype underlying obesity and related health risk may be determined by body composition during this critical period. Our previous research in children has consistently indicated that HA children accumulate greater amounts of fat, particularly in the intra-abdominal compartment, even at similar a BMI, and lower bone mineral content relative to EA children. The reason for these differences in body composition over the lifecourse is not clear. Racial/ethnic differences in risk factors for health, including 'thriftiness' in body fat accumulation are often evident before the age of 7, suggesting that the racial/ethnic differences in energy utilization and subsequent fat storage may be accounted for by genetic make-up, the environment (e.g. diet), or an interaction of the two. The physiologic or behavioral process(es) that cause(s) certain children to take a trajectory towards obesity while others accrue less fat is not known. However, the economic decision of fuel utilization is a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue (e.g. bone vs. fat) and this trait likely has a genetic component. This genetic component may be embedded in fat storage capacity evolved from gene by environment interactions that promote thrift, particularly conserved in some populations. Although genetic background plays a role, it not known whether there is a relationship between genetic background, known candidate genes or candidate pathways and environmental contributors (e.g. diet) that impact body composition trajectory. Of central importance to our understanding of early fat mass accumulation in health disparities are the mechanisms that lead to chronic disease progression. It is likely that variations within candidate genes may have a differential impact on individuals based on their genetic background. It is also probable that body composition is influenced by many genes, often within the same metabolic pathways, with small individual effects. These genes may not be significantly associated individually, but when examined as a unit (in a candidate pathway or gene-gene interaction framework) the association becomes significant. Further, children's early environmental exposures (e.g. diet) may interact with both genetic background and variations in candidate genes along resulting in alterations in body composition that predispose HA to excess fat accumulation throughout the lifecourse. To that end, the following specific aims will be evaluated: Aim 1. To examine the associations between genetic admixture and body composition in children aged 3-7 years after controlling for dietary intake.
- 1.Hypothesis 1.1: There is a direct association between Amerindian admixture and fat mass and in inverse association between Amerindian admixture and bone mass.
- 2.Hypothesis 1.2: There is a direct association between energy intake and fat accumulation and the relationship will be particularly evident in individuals with a greater proportion of Amerindian admixture.
- 3.Hypothesis 2.1: There is a direct association between Amerindian admixture and bone marrow fat.
- 4.Hypothesis 2.2: There is a direct association between energy intake and fat accumulation in bone marrow and the relationship will be particularly evident in individuals with a greater proportion of Amerindian admixture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 30, 2009
CompletedFirst Posted
Study publicly available on registry
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 25, 2019
November 1, 2019
1 year
December 30, 2009
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the effect of diet by gene interactions on body composition measures in Hispanic American children
1 year
Eligibility Criteria
Participants will be healthy children self-identifed as Hispanic American aged 3 to seven years
You may qualify if:
- Self-identified as Hispanic American
- Healthy, not under the care of a doctor
- Not taking medications known to affect body composition or metabolism
You may not qualify if:
- Not meeting above criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB
Birmingham, Alabama, 35294, United States
Biospecimen
Samples will be labeled with the study protocol number, a unique identifier, and the date of collection. Specimens will be obtained by the nursing staff at the PCIR. The PCIR processing lab will process the samples, which will then be stored in a locked freezer at -80oC in the restricted access CNRU Metabolism Core lab (WEBB 337).
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 30, 2009
First Posted
January 1, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
November 25, 2019
Record last verified: 2019-11