Genotype, Metabotype and Dietary HabitsPolyMicroBioNCT03318042
Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
A study testing Walnuts and Pomegranate juice in people with Genotype, Metabotype and Dietary Habits, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Genotype, Metabotype and Dietary Habits
- What is being tested?
- Walnuts and Pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2016to 2 Nov 2016
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy individuals aged 5 to 18 years.
- Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.
Who cannot join
- Known or suspected allergy or intolerance to nuts or pomegranate.
- Intake of antibiotics 1 month before the start of the study.
- If the participant could perceive stress or psychological damage due to his participation.
- Any other circumstance different from previous ones (illness, etc.), according to which it is considered that the intervention in the study may involve some type of affectation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.
Read the detailed description
The objective of this study is to investigate the possible association between 60 single nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease with the body mass index (BMI), intestinal microbiota related to the metabolism of polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.
The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to provide DNA for further genotyping.
- Conditions
- Genotype, Metabotype and Dietary Habits
- Being tested
- Walnuts, Pomegranate juice
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsOther
Also called Intake of walnuts
The group consumed a daily serving of walnuts (30 g) or 200 mL pomegranate juice for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek
Pomegranate juiceOther
Also called Intake of pomegranate juice
Those volunteers who were allergic to nuts consumed 200 mL pomegranate juice daily for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek
| Study group | Role | What they receive |
|---|---|---|
| Child-teenagers-walnuts-pomegranate | Experimental | Intake of walnuts or pomegranate juice for 3 days Receives: Other: Walnuts; Other: Pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyphenol metabotypes
Type of ellagic acid-derived microbial metabolites in urine
Measured: 1 to 3 months
Secondary outcomes (2)
Genotype
Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease
Measured: 1 to 6 months
Adherence to Mediterranean diet
Evaluation of the adherence to Mediterranean diet using validated questionnaires
Measured: 1 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Feb 2016
- Primary completion1 May 2016
- Study completion2 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genotype, Metabotype and Dietary HabitsStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain), IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain), IMDEA Food
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Juan C. Espin, PhD, Principal investigator, Spanish National Research Council (CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318042
- Sponsor's protocol ID
- AGL2015-64124-R(1)
- Acronym
- PolyMicroBio
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
- ClinicalTrials.gov ID
- NCT03318042
- Acronym / sponsor ID
- PolyMicroBio / AGL2015-64124-R(1)
- Conditions
- Genotype, Metabotype and Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain), IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain), IMDEA Food
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 2 Nov 2016 (actual)
- First posted
- 23 Oct 2017 (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.
The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.
Detailed description
The objective of this study is to investigate the possible association between 60 single nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease with the body mass index (BMI), intestinal microbiota related to the metabolism of polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.
The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to provide DNA for further genotyping.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child-teenagers-walnuts-pomegranate | Experimental | Other: Walnuts, Other: Pomegranate juiceIntake of walnuts or pomegranate juice for 3 days |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy individuals aged 5 to 18 years.
- Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.
Key exclusion criteria (4 listed)
- Known or suspected allergy or intolerance to nuts or pomegranate.
- Intake of antibiotics 1 month before the start of the study.
- If the participant could perceive stress or psychological damage due to his participation.
- Any other circumstance different from previous ones (illness, etc.), according to which it is considered that the intervention in the study may involve some type of affectation.
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 |
|---|---|---|
| WalnutsAlso: Intake of walnutsThe group consumed a daily serving of walnuts (30 g) or 200 mL pomegranate juice for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek | Other | Child-teenagers-walnuts-pomegranate |
| Pomegranate juiceAlso: Intake of pomegranate juiceThose volunteers who were allergic to nuts consumed 200 mL pomegranate juice daily for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek | Other | Child-teenagers-walnuts-pomegranate |
Primary outcome
Polyphenol metabotypes
Time frame: 1 to 3 months
Type of ellagic acid-derived microbial metabolites in urine
2 secondary outcomes
Genotype
Time frame: 1 to 6 months
Adherence to Mediterranean diet
Time frame: 1 to 3 months
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 24 Oct 2017.
- Individual participant dataSharing planned: No
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.
Juan C. Espin, PhD principal investigator
Spanish National Research Council (CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnuts and Pomegranate juice in people with Genotype, Metabotype and Dietary Habits, run by National Research Council, Spain at 1 site in Spain.
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 2 inclusion and 4 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 24 Oct 2017. 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 Spain. 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?
Polyphenol metabotypes (time frame: 1 to 3 months). 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 24 Oct 2017.