Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Obesity, Childhood Clinical Trial

Official title:

The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03994029
• Other study ID #: 2019-2278
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: St. Justine's Hospital
• Contact: Principal investigator
• Phone: 5143454931
• Email: ramy.el-jalbout.hsj[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

1. 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

2. Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function

3. Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Hyperplasia
• Intimal Hyperplasia
• Obesity, Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Rate of recruitment	Through study completion an average of 1 year
Primary	Retention:	The percentage of adolescents who agree to participate in the study and the retention	Through study completion an average of 1 year
Primary	Compliance with polyphenol supplementation	Percentage of compliance	Through study completion an average of 1 year
Primary	Effectiveness of the data collection procedure during the visits	Percentage of completed visits	Through study completion an average of 1 year
Primary	Adverse event	Percentage of adverse events	Through study completion an average of 1 year
Primary	Satisfaction of the participants and their point of view on the experience	Percentage of satisfaction of participants enrolled	Through study completion an average of 1 year
Primary	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.	Through study completion an average of 1 year
Secondary	Change in hepatic steatosis MR	mDixonQuant in percentage	At recruitment, after 60 days, and after 120 days
Secondary	Change in hepatic steatosis B-mode US	US liver echogenicity normal or increased	At recruitment, after 60 days, and after 120 days
Secondary	Change in intima media thickness (vascular compliance)	Measurement of carotid artery intima media thickness in mm	At recruitment, after 60 days, and after 120 days
Secondary	Metabolic syndrome	Insulin resistance evaluated by HOMA-IR mg\dl	At recruitment, after 60 days, and after 120 days
Secondary	Cholesterol	Triglyceride index (no unit)	At recruitment, after 60 days, and after 120 days
Secondary	Anthropometric measure	Body mass index	At recruitment, after 60 days, and after 120 days
Secondary	Inflammatory marker 1	CRP	At recruitment, after 60 days, and after 120 days
Secondary	Inflammatory marker 2	TNF alpha	At recruitment, after 60 days, and after 120 days
Secondary	Inflammatory marker 3	IL-6	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 1	Triglycerides	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 2	LDL	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 3	HDL	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 4	Apo AI	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 5	Apo B-100	At recruitment, after 60 days, and after 120 days
Secondary	Lipid markers 6	Adiponectin, leptin	At recruitment, after 60 days, and after 120 days
Secondary	Liver function test	ALT	At recruitment, after 60 days, and after 120 days
Secondary	Stool test	Gut microbiome composition	At recruitment, after 60 days, and after 120 days