Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-04

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition

NCT00004697

Fatty Liver

COMPLETED NA

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

NCT01934777

Fatty Liver Liver Fibrosis Obesity +2 more

COMPLETED PHASE3

Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

NCT04634643

NAFLD

RECRUITING

Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

NCT00655018

Inflammation Fibrosis Insulin Resistance

COMPLETED PHASE2/PHASE3

A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

NCT02787668

Non-alcoholic Fatty Liver Disease Childhood Obesity Insulin Resistance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Childhood Hepatic Steatosis Intimal Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polyphenol supplementation

120mg per day of powder polyphenol for 60 days

Group Type EXPERIMENTAL

Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness

Intervention Type DIETARY_SUPPLEMENT

Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness

Placebo

1 tab PO QD per day of placebo for 60 days

Group Type PLACEBO_COMPARATOR

Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness

Intervention Type DIETARY_SUPPLEMENT

Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No