METABOLIC SYNDROME, NAFLD, TYPE 2 DIABETES
Conditions
Keywords
Pediatrics, Adolescents, NAFLD, Spectroscopy, Type 2 diabetes
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.
Interventions
DIETARY_SUPPLEMENTResveratrol
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
DSM Nutritional Products, Inc.
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Resveratrol as ResVida (TM) compared to a placebo
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/ Adverse Event Outcome | One week | 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 |
| Efficacy Outcome | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Outcome | Week 4 | To determine efficacy of resveratrol to reduce whole body insulin resistance in overweight and obese adolescents with NAFL. The 3-hr frequently sampled oral glucose tolerance test (OGTT) using a standard 75-gram-glucose-load will be performed at the baseline visit and after completion of supplementation (day 30; visit 3). Blood samples will be collected at 20, 30, 60, 90, 120 and 180 minutes after ingestion of glucose will be used for the determination of insulin sensitivity using the Matsuda index |
Countries
Canada
Outcome results
None listed