Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents

Phase 2

Completed

• Conditions: TYPE 2 DIABETES; METABOLIC SYNDROME; NAFLD
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Resveratrol

• Registration Number: NCT02216552
• Lead Sponsor: University of Manitoba

Brief Summary

The current project is designed as a 30-day pilot trial to demonstrate the safety and tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and improve insulin sensitivity to prevent type 2 diabetes.

Detailed Description

Pilot study of 10 overweight or obese children with MRS determined fatty liver randomized to resveratrol or placebo. Primary outcome measures include change in liver triglyceride content as determined by MRS and improvement in insulin resistance as determined by the area under the curve of glucose excursion during a 75 gram oral glucose tolerance test.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Study Start: 2015-08
• Primary Completion: 2017-01-01
• Study Completion: 2017-03-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 13 to <18 years of age
• BMI considered overweight (BMI > 25 kg/m2 ) or obese (BMI > 30 kg/m2 )
• Confirmed 1H-MRS defined hepatic steatosis (>5.5% fat/water)
• Parent/Guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
• Sexually active subjects must be willing to use an acceptable method of contraception
• Females of child bearing potential must have a negative pregnancy test at screening.

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Exclusion Criteria

• The use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
• Adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:

type 2 diabetes; present or previous malignancy renal disease, hypertension (anyone who has BPs over the 99th percentile for age and gender) or liver disease;

• significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
• self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
• report using non-prescription recreational drugs;
• allergies or sensitivities to any of the ingredients in the investigational product or placebo;
• females breastfeeding at screening or planning on becoming pregnant at any time during the study;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intervention: Placebo Control Oral supplementation of placebo twice daily (with breakfast and dinner) for a total duration of 30 days.
Resveratrol	Resveratrol	Intervention: Resveratrol Oral supplementation of resveratrol (ResVida) 75 mg twice daily (with breakfast and dinner) for a total daily dose of 150 mg for the duration of 30 days.

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome	Week 4	To determine efficacy of resveratrol to reduce hepatic and cardiac triglyceride content in adolescents with NAFL MR spectroscopy will be performed using a 3.0-Tesla whole-body magnet. Sixty-four spectra will be acquired and averaged for the determination of intracellular water and lipid content. LCModel software will be used to isolate and quantify lipid and water peaks. Hepatic steatosis will be defined as hepatic triglyceride content of \>.5% fat/water.
Safety/ Adverse Event Outcome	Week 8	1. Primary Side effect profile determined by participant interview. Side effect profile determined by serum biochemistry: AST, ALT, total and conjugated bilirubin, Creatinine, sodium, potassium, calcium, magnesium, chloride and TC02, haemoglobin, haematocrit, white blood cell and platelet counts, erythrocytes, and fasting lipid levels (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides). Fasting glucose and insulin levels. PT/INR and PTT levels.; 2. Vital signs

Secondary Outcome Measures

Name	Time	Method
Efficacy Outcome	Week 4	To determine the effect of resveratrol supplementation on serum markers of inflammation. Inflammatory markers will be assessed by measurements of circulating adiponectin, leptin, CRP, ESR, TNFalpha, IL-1beta, IL-6, and IL-10, using commercially available ELISA assays

Trial Locations

Locations (1)

Children's Hospital Research Institute of Manitoba/University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada