Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04770311 |
| Other study ID # |
Pro00107438 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2021 |
| Est. completion date |
November 20, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to measure the effectiveness of a microbiome diet using direct
food provision on dietary quality and microbiome composition among children with obesity.
This study proposes a pilot randomized, controlled clinical trial in children of a dietary
intervention informed by microbiome science.
Description:
Childhood obesity is a global health crisis and contributes to shortened life expectancy in
the US, with higher rates and more serious co-morbidities among minorities. Existing dietary
interventions demonstrate significant heterogeneity of treatment response among diverse
populations, and clear information to tailor diet to individual-level characteristics is not
yet available. Recent science suggests that the gut microbiome may in part explain
inter-individual variation in pediatric obesity and treatment response. Intestinal microbial
communities play causal roles in models of obesity and are distinct between individuals.
However, it is unknown how the microbiome mediates response to existing dietary guidelines
for children with obesity.
Evidence-based nutritional standards for treatment of pediatric obesity are well-established,
and aim to reduce body mass index and cardio-metabolic risk. However, these standards have
not translated into reduced prevalence of obesity among children, particularly those in
racially diverse and low-income groups. One explanation is the significant inter-individual
variability in metabolic response to dietary interventions, suggesting that certain food
components in a diet may benefit some individuals more than others. Another explanation is
that dietary adherence is highly variable, and requires skills or resources not available to
all people. For example, translating dietary recommendations into food procurement,
preparation, and consumption requires baseline levels of educational attainment, child
acceptability of foods, diet compatibility with cultural preferences, and may be seen as
time-consuming. These obstacles are hard to overcome for children and families from
low-income and minority groups, who are known to have low show rates and engagement in
nutrition studies despite being at disproportionate risk of diseases like obesity and
metabolic disease. The one-size-fits-all approach to dietary recommendations is failing the
most vulnerable children in the nation.
Recent science suggests that the gut microbiome provides new opportunities to address these
long-standing challenges. Microbiome transplant experiments in mice have demonstrated that
increased adiposity can be conferred from bacterial communities originating from individuals
with obesity. Furthermore, variation in microbiome composition between individuals can
predict response to dietary intervention, suggesting a mechanism for why certain individuals
lose weight on specific diets and other individuals do not. Another intriguing aspect of
microbiome science is how its adoption could introduce new methodological techniques to
obesity treatment. In particular, the plummeting costs and turnaround times of metagenomic
DNA sequencing used in microbiome research opens new opportunities for rapidly providing
biomarker information to a wide number of people. |
No evidence exists that describes microbiome signatures with objective measures of dietary
quality among children with obesity. The work to be completed here will be a vital first step
towards integrating the promise of microbiome science into the treatment of pediatric
obesity. Our team is uniquely suited to take this step as leaders in microbiome science
(David) and childhood obesity (Armstrong). By working together to predict how individual
microbiome variation shapes responses to diet therapy, an important step towards
personalizing dietary recommendations for children based on gut microbiome signatures that
predict the best outcome will be taken. In addition, linking microbial signatures to measures
of diet quality will provide researchers with much-needed molecular tools for assessing
dietary compliance and intervention success. Finally, insights into the impact of receiving
metagenomic data on children's' motivation towards healthy behaviors could provide behavioral
and implementation scientists with new tools for improving adherence with obesity treatment
