Clinical trial NCT02216552: Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents
Official title: Safety and Efficacy of Resveratrol for the Treatment of Non-Alcoholic Fatty Liver Disease and Associated Insulin Resistance in Overweight and Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: NAFLD
TYPE 2 DIABETES
METABOLIC SYNDROME
Keywords: Pediatrics
Adolescents
NAFLD
Spectroscopy
Type 2 diabetes
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2014-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Resveratrol as ResVida (TM) compared to a placebo
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

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;

Primary outcomes:
measure: Safety/ Adverse Event Outcome
timeFrame: One week
measure: Safety/ Adverse Event Outcome
timeFrame: Week 2
measure: Safety/ Adverse Event Outcome
timeFrame: Week 3
measure: Safety/ Adverse Event Outcome
timeFrame: Week 4
measure: Safety/ Adverse Event Outcome
timeFrame: Week 8
measure: Efficacy Outcome
timeFrame: Week 4
Secondary outcomes:
measure: Efficacy Outcome
timeFrame: Week 4
measure: Efficacy Outcome
timeFrame: Week 4
measure: Efficacy Outcome
timeFrame: Week 1
measure: Efficacy Outcome
timeFrame: Week 2
measure: Efficacy Outcome
timeFrame: Week 3
measure: Efficacy Outcome
timeFrame: Week 4
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Children's Hospital Research Institute of Manitoba/University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Brandy A Wicklow, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: