NAFLDPhase 2/3NCT02216552
Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents
A Phase 2/3 study testing Resveratrol in people with NAFLD and TYPE 2 DIABETES, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- NAFLD, TYPE 2 DIABETES, METABOLIC SYNDROME
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to 20 Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: Safety and Efficacy of Resveratrol for the Treatment of Non-Alcoholic Fatty Liver Disease and Associated Insulin Resistance in Overweight and Obese Adolescents
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.
Read the 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
- Being tested
- Resveratrol, Placebo
- Keywords
- Pediatrics, Adolescents, NAFLD, Spectroscopy, Type 2 diabetes
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Also called ResVida (Registered Trademark of DSM)
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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/ Adverse Event Outcome
- 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.
- Vital signs
Measured: One week
Safety/ Adverse Event Outcome
- 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.
- Vital signs
Measured: Week 2
Safety/ Adverse Event Outcome
- 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.
- Vital signs
Measured: Week 3
Safety/ Adverse Event Outcome
- 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.
- Vital signs
Measured: Week 4
Safety/ Adverse Event Outcome
- 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.
- Vital signs
Measured: 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.
Measured: Week 4
Secondary outcomes (6)
Efficacy Outcome
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
Measured: Week 4
Efficacy Outcome
To determine the effects of resveratrol on cardiac function and morphology in the study population. Cardiac function and morphology will be measured using a cardiac ultrasound at baseline (day 0) and at completion of supplementation (day 30; visit 3).
Measured: Week 4
Efficacy Outcome
To determine the effect of resveratrol supplementation on serum markers of inflammation. Inflammatory markers will be assessed by measurements of circulating adiponectin, leptin, CRP, ESR, TNFalpha, IL-1beta, IL-6, and IL-10, using commercially available ELISA assays.
Measured: Week 1
Efficacy Outcome
To determine the effect of resveratrol supplementation on serum markers of inflammation. Inflammatory markers will be assessed by measurements of circulating adiponectin, leptin, CRP, ESR, TNFalpha, IL-1beta, IL-6, and IL-10, using commercially available ELISA assays.
Measured: Week 2
Efficacy Outcome
To determine the effect of resveratrol supplementation on serum markers of inflammation. Inflammatory markers will be assessed by measurements of circulating adiponectin, leptin, CRP, ESR, TNFalpha, IL-1beta, IL-6, and IL-10, using commercially available ELISA assays
Measured: Week 3
Efficacy Outcome
To determine the effect of resveratrol supplementation on serum markers of inflammation. Inflammatory markers will be assessed by measurements of circulating adiponectin, leptin, CRP, ESR, TNFalpha, IL-1beta, IL-6, and IL-10, using commercially available ELISA assays
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2015
- Primary completion1 Jan 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Resveratrol as ResVida (TM) compared to a placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Dr. Brandy Wicklow, University of Manitoba
- Investigators
- Brandy A Wicklow, MD, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216552
- Sponsor's protocol ID
- 2013-01-15-RESV
- Status last verified
- May 2017
- First submitted
- 12 Aug 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Resveratrol for the Treatment of Non-Alcoholic Fatty Liver Disease and Associated Insulin Resistance in Overweight and Obese Adolescents
- ClinicalTrials.gov ID
- NCT02216552
- Acronym / sponsor ID
- 2013-01-15-RESV
- Conditions
- NAFLD, TYPE 2 DIABETES, METABOLIC SYNDROME
- Keywords
- Pediatrics, Adolescents, NAFLD, Spectroscopy, Type 2 diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Aug 2015
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Resveratrol as ResVida (TM) compared to a placebo
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolIntervention: 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention: Placebo Control Oral supplementation of placebo twice daily (with breakfast and dinner) for a total duration of 30 days. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: ResVida (Registered Trademark of DSM)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 supplement | Resveratrol |
| PlaceboAll 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 supplement | Placebo |
Primary outcome
Safety/ Adverse Event Outcome
Time frame: 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
Safety/ Adverse Event Outcome
Time frame: Week 2
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
Safety/ Adverse Event Outcome
Time frame: Week 3
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
Safety/ Adverse Event Outcome
Time frame: Week 4
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
Safety/ Adverse Event Outcome
Time frame: Week 8
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
Efficacy Outcome
Time frame: 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.
6 secondary outcomes
Efficacy Outcome
Time frame: Week 4
Efficacy Outcome
Time frame: Week 4
Efficacy Outcome
Time frame: Week 1
Efficacy Outcome
Time frame: Week 2
Efficacy Outcome
Time frame: Week 3
Efficacy Outcome
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandy A Wicklow, MD, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resveratrol in people with NAFLD and TYPE 2 DIABETES, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/ Adverse Event Outcome (time frame: One week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.