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

NCT ID: NCT02216552

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-20

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.

Conditions

NAFLD; TYPE 2 DIABETES; METABOLIC SYNDROME

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.

Interventions

Resveratrol

All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

ResVida (Registered Trademark of DSM)

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;

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Brandy Wicklow

Principal Investigator MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandy A Wicklow, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Children's Hospital Research Institute of Manitoba/University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

2013-01-15-RESV

Identifier Type: -

Identifier Source: org_study_id