Obesity, ChildhoodNCT03994029
Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
A study testing Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness in people with Obesity, Childhood and Hepatic Steatosis, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Childhood, Hepatic Steatosis, Intimal Hyperplasia
- What is being tested?
- Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2021to Dec 2024
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 12 to 18 years
- BMI percentile > 85th for age and sex
- Diagnosis of hepatic steatosis on imaging (ultrasound or MR).
- Diagnosis of hepatic steatosis, NASH, or fibrosis on liver biopsy.
- Elevated alanine aminotransferase (ALT) enzyme level.
- Index of hepatic steatosis 8xALT/AST + BMI (+2 for girls) > 30.
Who cannot join
- Known chronic systematic diseases
- Any other serious conditions which, according to the doctor's judgment, would prevent compliance and safe participation in the study until completion.
- Exclusion criteria to be validated when contacting the participants and their parents/tutors:
- Being pregnant.
- Taking all kinds of prescription or over-the-counter natural health products/natural supplements/vitamins on an ongoing basis or within the next four months, excluding vitamin D.
- Weight loss of 5% to 10% of the usual weight in the last six months before recruitment or weight change of 5% in the last three months.
Show all 9Show fewer
- Alcohol consumption > two drinks/day or > one day/week.
- Known peanut allergy and/or to the medicinal ingredients contained in the active polyphenol supplement: elderberry, haskap, black chokeberry, blueberry, blackcurrant.
- Any contraindications for MRI.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T1C5
Ramy El Jalbout, MD, ramy.jalbout@gmail.com
Anik Cloutier, MSc, anik.cloutier2.hsj@ssss.gouv.qc.ca
About this study
Official title: The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents
The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy
Read the detailed description
- Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation: Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study
- Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function
- Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children
- Conditions
- Obesity, Childhood, Hepatic Steatosis, Intimal Hyperplasia
- Being tested
- Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
- Medical subject headings
- Pediatric Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thicknessDietary supplement
Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol supplementation | Experimental | 120mg per day of powder polyphenol for 60 days Receives: Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness |
| Placebo | Placebo comparator | 1 tab PO QD per day of placebo for 60 days Receives: Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Rate of recruitment
Measured: Through study completion an average of 1 year
Retention:
The percentage of adolescents who agree to participate in the study and the retention
Measured: Through study completion an average of 1 year
Compliance with polyphenol supplementation
Percentage of compliance
Measured: Through study completion an average of 1 year
Effectiveness of the data collection procedure during the visits
Percentage of completed visits
Measured: Through study completion an average of 1 year
Adverse event
Percentage of adverse events
Measured: Through study completion an average of 1 year
Satisfaction of the participants and their point of view on the experience
Percentage of satisfaction of participants enrolled
Measured: Through study completion an average of 1 year
Sample size calculation for a randomized controlled study
A sample size for a future randomized controlled study will be calculated from the estimates obtained during this pilot study.
Measured: Through study completion an average of 1 year
Secondary outcomes (17)
Change in hepatic steatosis MR
mDixonQuant in percentage
Measured: At recruitment, after 60 days, and after 120 days
Change in hepatic steatosis B-mode US
US liver echogenicity normal or increased
Measured: At recruitment, after 60 days, and after 120 days
Change in intima media thickness (vascular compliance)
Measurement of carotid artery intima media thickness in mm
Measured: At recruitment, after 60 days, and after 120 days
Metabolic syndrome
Insulin resistance evaluated by HOMA-IR mg\dl
Measured: At recruitment, after 60 days, and after 120 days
Cholesterol
Triglyceride index (no unit)
Measured: At recruitment, after 60 days, and after 120 days
Anthropometric measure
Body mass index
Measured: At recruitment, after 60 days, and after 120 days
Inflammatory marker 1
CRP
Measured: At recruitment, after 60 days, and after 120 days
Inflammatory marker 2
TNF alpha
Measured: At recruitment, after 60 days, and after 120 days
Inflammatory marker 3
IL-6
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 1
Triglycerides
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 2
LDL
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 3
HDL
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 4
Apo AI
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 5
Apo B-100
Measured: At recruitment, after 60 days, and after 120 days
Lipid markers 6
Adiponectin, leptin
Measured: At recruitment, after 60 days, and after 120 days
Liver function test
ALT
Measured: At recruitment, after 60 days, and after 120 days
Stool test
Gut microbiome composition
Measured: At recruitment, after 60 days, and after 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start4 Jul 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy El Jalbout, St. Justine's Hospital
- Investigators
- Ramy El Jalbout, MD MSc, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994029
- Sponsor's protocol ID
- 2019-2278
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2019
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moretti JB, Drouin A, Truong C, Youn E, Cloutier A, Alvarez F, Paganelli M, Grzywacz K, Jantchou P, Dubois J, Levy E, El Jalbout R. Effects of polyphenol supplementation on hepatic steatosis, intima-media thickness and non-invasive vascular elastography in obese adolescents: a pilot study protocol. BMJ Open. 2024 Jan 30;14(1):e074882. doi: 10.1136/bmjopen-2023-074882.
PubMed 38296273
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents
- ClinicalTrials.gov ID
- NCT03994029
- Acronym / sponsor ID
- 2019-2278
- Conditions
- Obesity, Childhood, Hepatic Steatosis, Intimal Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2019 (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 main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy
Detailed description
- Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation: Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study
- Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function
- Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenol supplementation | Experimental | Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness120mg per day of powder polyphenol for 60 days |
| Placebo | Placebo comparator | Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness1 tab PO QD per day of placebo for 60 days |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 12 to 18 years
- BMI percentile > 85th for age and sex
- Diagnosis of hepatic steatosis on imaging (ultrasound or MR).
- Diagnosis of hepatic steatosis, NASH, or fibrosis on liver biopsy.
- Elevated alanine aminotransferase (ALT) enzyme level.
Key exclusion criteria (9 listed)
- Known chronic systematic diseases
- Any other serious conditions which, according to the doctor's judgment, would prevent compliance and safe participation in the study until completion.
- Exclusion criteria to be validated when contacting the participants and their parents/tutors:
- Being pregnant.
- Taking all kinds of prescription or over-the-counter natural health products/natural supplements/vitamins on an ongoing basis or within the next four months, excluding vitamin D.
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 |
|---|---|---|
| Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thicknessMeasurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness | Dietary supplement | Placebo, Polyphenol supplementation |
Primary outcome
Recruitment
Time frame: Through study completion an average of 1 year
Rate of recruitment
Retention:
Time frame: Through study completion an average of 1 year
The percentage of adolescents who agree to participate in the study and the retention
Compliance with polyphenol supplementation
Time frame: Through study completion an average of 1 year
Percentage of compliance
Effectiveness of the data collection procedure during the visits
Time frame: Through study completion an average of 1 year
Percentage of completed visits
Adverse event
Time frame: Through study completion an average of 1 year
Percentage of adverse events
Satisfaction of the participants and their point of view on the experience
Time frame: Through study completion an average of 1 year
Percentage of satisfaction of participants enrolled
Sample size calculation for a randomized controlled study
Time frame: Through study completion an average of 1 year
A sample size for a future randomized controlled study will be calculated from the estimates obtained during this pilot study.
17 secondary outcomes
Change in hepatic steatosis MR
Time frame: At recruitment, after 60 days, and after 120 days
Change in hepatic steatosis B-mode US
Time frame: At recruitment, after 60 days, and after 120 days
Change in intima media thickness (vascular compliance)
Time frame: At recruitment, after 60 days, and after 120 days
Metabolic syndrome
Time frame: At recruitment, after 60 days, and after 120 days
Cholesterol
Time frame: At recruitment, after 60 days, and after 120 days
Anthropometric measure
Time frame: At recruitment, after 60 days, and after 120 days
Inflammatory marker 1
Time frame: At recruitment, after 60 days, and after 120 days
Inflammatory marker 2
Time frame: At recruitment, after 60 days, and after 120 days
Inflammatory marker 3
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 1
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 2
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 3
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 4
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 5
Time frame: At recruitment, after 60 days, and after 120 days
Lipid markers 6
Time frame: At recruitment, after 60 days, and after 120 days
Liver function test
Time frame: At recruitment, after 60 days, and after 120 days
Stool test
Time frame: At recruitment, after 60 days, and after 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 38296273Moretti JB, Drouin A, Truong C, Youn E, Cloutier A, Alvarez F, Paganelli M, Grzywacz K, Jantchou P, Dubois J, Levy E, El Jalbout R. Effects of polyphenol supplementation on hepatic steatosis, intima-media thickness and non-invasive vascular elastography in obese adolescents: a pilot study protocol. BMJ Open. 2024 Jan 30;14(1):e074882. doi: 10.1136/bmjopen-2023-074882.
- Individual participant dataSharing planned: No
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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.
Ramy El Jalbout, MD MSc principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness in people with Obesity, Childhood and Hepatic Steatosis, run by St. Justine's Hospital at 1 site in Canada.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Principal investigator (5143454931, ramy.el-jalbout.hsj@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Through study completion an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994029, which also lists 1 linked publication.
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 23 Jan 2024.