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

NCT02216552 | Completed Phase 2 DMC

• 1 other identifier: 2013-01-15-RESV
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; TYPE 2 DIABETES; METABOLIC SYNDROME

Keywords

Pediatrics; Adolescents; NAFLD; Spectroscopy; Type 2 diabetes

Outcome Measures

Primary Outcomes (6)

• Safety/ Adverse Event Outcome

  1. Primary Side effect profile determined by participant interview and serum biochemistry. 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

  One week

• Safety/ Adverse Event Outcome

  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

  Week 2

• Safety/ Adverse Event Outcome

  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

  Week 3

• Safety/ Adverse Event Outcome

  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

  Week 4

• Safety/ Adverse Event Outcome

  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

  Week 8

• Efficacy Outcome

  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.

  Week 4

Secondary Outcomes (6)

• Efficacy Outcome

  Week 4

• Efficacy Outcome

  Week 4

• Efficacy Outcome

  Week 1

• Efficacy Outcome

  Week 2

• Efficacy Outcome

  Week 3

Study Arms (2)

Resveratrol

EXPERIMENTAL

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.

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Resveratrol 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.

Also known as: ResVida (Registered Trademark of DSM)

Resveratrol

Placebo 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

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Manitoba: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

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

Winnipeg, Manitoba, R3E 3P4, Canada

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Metabolic Syndrome

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Brandy A Wicklow, MD, MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD

Model Details: Resveratrol as ResVida (TM) compared to a placebo

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: March 20, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)