Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

NCT03994029 | Unknown DMC

• 1 other identifier: 2019-2278
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity, Childhood; Hepatic Steatosis; Intimal Hyperplasia

Outcome Measures

Primary Outcomes (7)

• Recruitment

  Rate of recruitment

  Through study completion an average of 1 year

• Retention:

  The percentage of adolescents who agree to participate in the study and the retention

  Through study completion an average of 1 year

• Compliance with polyphenol supplementation

  Percentage of compliance

  Through study completion an average of 1 year

• Effectiveness of the data collection procedure during the visits

  Percentage of completed visits

  Through study completion an average of 1 year

• Adverse event

  Percentage of adverse events

  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

  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.

  Through study completion an average of 1 year

Secondary Outcomes (17)

• Change in hepatic steatosis MR

  At recruitment, after 60 days, and after 120 days

• Change in hepatic steatosis B-mode US

  At recruitment, after 60 days, and after 120 days

• Change in intima media thickness (vascular compliance)

  At recruitment, after 60 days, and after 120 days

• Metabolic syndrome

  At recruitment, after 60 days, and after 120 days

• Cholesterol

  At recruitment, after 60 days, and after 120 days

Study Arms (2)

Polyphenol supplementation

EXPERIMENTAL

120mg per day of powder polyphenol for 60 days

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

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

Interventions

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

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

Placebo; Polyphenol supplementation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38296273 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Ramy El Jalbout, MD MSc

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal investigator

CONTACT

5143454931; ramy.el-jalbout.hsj@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 21, 2019
• Study Start: July 4, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)