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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02216552
• Date of registration: 12/08/2014
• Prospective Registration: Yes
• Primary sponsor: University of Manitoba
• Public title: Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents
• Scientific title: Safety and Efficacy of Resveratrol for the Treatment of Non-Alcoholic Fatty Liver Disease and Associated Insulin Resistance in Overweight and Obese Adolescents
• Date of first enrolment: August 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02216552
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Brandy A Wicklow, MD, MSc
• Affiliation: University of Manitoba

Key inclusion & exclusion 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;



Age minimum: 13 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

TYPE 2 DIABETES

METABOLIC SYNDROME

NAFLD

Intervention(s)

Dietary Supplement: Resveratrol

Dietary Supplement: Placebo

Primary Outcome(s)

Safety/ Adverse Event Outcome [Time Frame: Week 4]

Safety/ Adverse Event Outcome [Time Frame: Week 2]

Safety/ Adverse Event Outcome [Time Frame: Week 8]

Efficacy Outcome [Time Frame: Week 4]

Safety/ Adverse Event Outcome [Time Frame: One week]

Safety/ Adverse Event Outcome [Time Frame: Week 3]

Secondary Outcome(s)

Efficacy Outcome [Time Frame: Week 2]

Efficacy Outcome [Time Frame: Week 4]

Efficacy Outcome [Time Frame: Week 1]

Efficacy Outcome [Time Frame: Week 3]

Secondary ID(s)

2013-01-15-RESV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DSM Nutritional Products, Inc.