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

University of Manitoba

Status and phase: Completed; Phase 3; Phase 2

Conditions: METABOLIC SYNDROME; NAFLD; TYPE 2 DIABETES

Treatments: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02216552

2013-01-15-RESV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Resveratrol

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Resveratrol

Placebo

Placebo Comparator group

Description:

Intervention: Placebo Control Oral supplementation of placebo twice daily (with breakfast and dinner) for a total duration of 30 days.

Treatment:

Dietary Supplement: Placebo