Gastrointestinal MicrobiomeNCT03612479
Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)
A study testing KIDFIT Healthy and KIDFIT Safe in people with Gastrointestinal Microbiome and Metabolome, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Gastrointestinal Microbiome, Metabolome, Pediatric Obesity
- What is being tested?
- KIDFIT Healthy and KIDFIT Safe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- participating in KIDFIT (NCT03405246)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Preventive Medicine
Chicago, Illinois, 60611
About this study
Official title: 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).
Read the 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.
- Conditions
- Gastrointestinal Microbiome, Metabolome, Pediatric Obesity, Dietary Approaches to Stop Hypertension
- Being tested
- KIDFIT Healthy, KIDFIT Safe
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDFIT HealthyBehavioural
Also called Intervention Group
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.
KIDFIT SafeBehavioural
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| KIDFIT Healthy | Experimental | Not described Receives: Behavioral: KIDFIT Healthy |
| KIDFIT Safe | Active comparator | Not described Receives: Behavioral: KIDFIT Safe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
abundances of gut microbial taxa, communities, and metabolic pathways activity
Measured: changes from baseline to 12 months
Blood metabolome
abundances of blood metabolites, metabolic networks, and metabolic pathways activity
Measured: changes from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start10 Jul 2018
- Primary completion9 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Amanda Marma, Northwestern University
- Investigators
- Amanda Marma Perak, MD MS, Principal investigator, Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612479
- Sponsor's protocol ID
- STU00207041
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2018
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the NIH policy to share genomic data from supported studies, raw and processed data from microbiomes, metabolomes, and relevant associated data will be submitted to public data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03612479
- Acronym / sponsor ID
- STU00207041
- Conditions
- Gastrointestinal Microbiome, Metabolome, Pediatric Obesity, Dietary Approaches to Stop Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIDFIT Healthy | Experimental | Behavioral: KIDFIT Healthy |
| KIDFIT Safe | Active comparator | Behavioral: KIDFIT Safe |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- participating in KIDFIT (NCT03405246)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIDFIT HealthyAlso: Intervention GroupThe 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. | Behavioural | KIDFIT Healthy |
| KIDFIT SafeAlso: Control GroupThe 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. | Behavioural | KIDFIT Safe |
Primary outcome
Gut microbiome
Time frame: changes from baseline to 12 months
abundances of gut microbial taxa, communities, and metabolic pathways activity
Blood metabolome
Time frame: changes from baseline to 12 months
abundances of blood metabolites, metabolic networks, and metabolic pathways activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Yes. In accordance with the NIH policy to share genomic data from supported studies, raw and processed data from microbiomes, metabolomes, and relevant associated data will be submitted to public data repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Marma Perak, MD MS principal investigator
Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIDFIT Healthy and KIDFIT Safe in people with Gastrointestinal Microbiome and Metabolome, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: changes from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.