Metabolic SyndromeFRUVEDomicsNCT03115866
FRUVEDomics: Behavioral Intervention in Young Adults to Identify Metabolomics and Microbiome Risk
A study testing FRUVEDomics in people with Metabolic Syndrome, run by West Virginia University.
Trial summary
Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- FRUVEDomics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2015to 15 Jan 2019
- Phase
- Interventional
- 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 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 28 years of age
- either showing evidence of metabolic syndrome or at risk for metabolic syndrome
Who cannot join
- no evidence of metabolic syndrome or of being at-risk for metabolic syndrome
About this study
Official title: FRUVEDomics Study: Use of a Behavioral Nutrition Intervention in Young Adults to Identify Modifiable Metabolomics and Microbiome Risk
Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. The purpose of this project is to evaluate the impact of the FRUVEDomics behavior intervention on dietary behaviors and metabolic parameters on young adults "at-risk" of disease. FRUVEDomics is an 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure "risk" status for chronic disease. Subjects were randomized into one of three nutritional intervention groups: 1) "FRUVED" (50% fruit \& vegetable), 2) "FRUVED+LRC" (50% fruit \& vegetable plus low refined carbohydrate), and 3) "FRUVED+LF" (50% fruit \& vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
Read the detailed description
Background: Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28), further creating a need for interventions that will improve later quality of life. Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. In the past decade, there has been considerable research on behavior interventions focusing on dietary change for the promotion of health. However, successful theory-based dietary behavioral interventions for young adults who follow poor lifestyle habits, are limited. The purpose of this paper is to evaluate the impact of the FRUVEDomics pilot study on dietary behaviors and metabolic parameters on young adults "at-risk" of disease.
Methods: An 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, was conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure "risk" status for chronic disease. Subjects (n=36) were randomized into one of three nutritional intervention groups; 1) "FRUVED" (50% fruit \& vegetable), 2) "FRUVED+LRC" (50% fruit \& vegetable plus low refined carbohydrate), and 3) "FRUVED+LF" (50% fruit \& vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were successfully delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
Specific Aim: Identify novel metabolomic and microbiome phenotypes in response to fruit and vegetable diet intervention in young adults with and without metabolic syndrome (MetS).
Hypothesis 1: Diet consisting of 50% fruit \& vegetable consumption (FRUVED diet) will improve metabolic health as evidenced by lower plasma concentrations of adipokines, inflammatory mediators, and ceramides.
Hypothesis 2. Diet induced changes in the metabolome and micobiome will reveal novel phenotypes that have the potential to be used as new diagnostic biomarkers to distinguish between MetS and healthy adolescents.
- Conditions
- Metabolic Syndrome
- Being tested
- FRUVEDomics
- Keywords
- Healthy Diet, Fruits and Vegetables, Metabolome, Microbiome, Young Adults
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRUVEDomicsBehavioural
FRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| FRUVED | Experimental | Individuals that are at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet with 50% fruit and vegetables. Receives: Behavioral: FRUVEDomics |
| FRUVED + LRC | Experimental | Individuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low refined carbohydrates. Receives: Behavioral: FRUVEDomics |
| FRUVED + LF | Experimental | Individuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low fat. Receives: Behavioral: FRUVEDomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic parameters at 8 weeks
Metabolomic measures via blood sample
Measured: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
Secondary outcomes (4)
Change in microbiome parameters at 8 weeks
Microbiome measures via stool sample
Measured: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
Change in Weight and BMI at 8 weeks
calculation with body weight and height
Measured: 8 weeks
Change in Blood pressure at 8 weeks
Blood pressure, standard measurement equipment
Measured: 8 weeks
Change in Arterial stiffness at 8 weeks
Measured via dopler
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Jan 2015
- Primary completion15 Dec 2016
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 2 interventions evaluated against the other and a control.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee, University of New Hampshire
- Responsible party
- Sponsor
- Investigators
- Melissa D. Olfert, DrPH, RDN, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115866
- Sponsor's protocol ID
- 1409433435
- Other IDs
- 2014-67001-21851, 2014
- Acronym
- FRUVEDomics
- Status last verified
- Sep 2024
- First submitted
- 5 Apr 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this time.
Publications
Tabas I. Cholesterol in health and disease. J Clin Invest. 2002 Sep;110(5):583-90. doi: 10.1172/JCI16381. No abstract available.
PubMed 12208856Barsh GS, Schwartz MW. Genetic approaches to studying energy balance: perception and integration. Nat Rev Genet. 2002 Aug;3(8):589-600. doi: 10.1038/nrg862. No abstract available.
PubMed 12154382Seeman E. Pathogenesis of bone fragility in women and men. Lancet. 2002 May 25;359(9320):1841-50. doi: 10.1016/S0140-6736(02)08706-8.
PubMed 12044392Catalan U, Rodriguez MA, Ras MR, Macia A, Mallol R, Vinaixa M, Fernandez-Castillejo S, Valls RM, Pedret A, Griffin JL, Salek R, Correig X, Motilva MJ, Sola R. Biomarkers of food intake and metabolite differences between plasma and red blood cell matrices; a human metabolomic profile approach. Mol Biosyst. 2013 Jun;9(6):1411-22. doi: 10.1039/c3mb25554a. Epub 2013 Mar 14.
PubMed 23493899German JB, Roberts MA, Fay L, Watkins SM. Metabolomics and individual metabolic assessment: the next great challenge for nutrition. J Nutr. 2002 Sep;132(9):2486-7. doi: 10.1093/jn/132.9.2486. No abstract available.
PubMed 12221197Morrow DA. Fat cow syndrome. J Dairy Sci. 1976 Sep;59(9):1625-9. doi: 10.3168/jds.S0022-0302(76)84415-3.
PubMed 965540McCann JP, Reimers TJ. Insulin response to glucose in estrous and diestrous obese and lean heifers. J Anim Sci. 1985 Sep;61(3):619-23. doi: 10.2527/jas1985.613619x.
PubMed 3905736Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477Holland WL, Summers SA. Sphingolipids, insulin resistance, and metabolic disease: new insights from in vivo manipulation of sphingolipid metabolism. Endocr Rev. 2008 Jun;29(4):381-402. doi: 10.1210/er.2007-0025. Epub 2008 May 1.
PubMed 18451260Long SD, Pekala PH. Lipid mediators of insulin resistance: ceramide signalling down-regulates GLUT4 gene transcription in 3T3-L1 adipocytes. Biochem J. 1996 Oct 1;319 ( Pt 1)(Pt 1):179-84. doi: 10.1042/bj3190179.
PubMed 8870666Kanety H, Hemi R, Papa MZ, Karasik A. Sphingomyelinase and ceramide suppress insulin-induced tyrosine phosphorylation of the insulin receptor substrate-1. J Biol Chem. 1996 Apr 26;271(17):9895-7. doi: 10.1074/jbc.271.17.9895.
PubMed 8626623Shah C, Yang G, Lee I, Bielawski J, Hannun YA, Samad F. Protection from high fat diet-induced increase in ceramide in mice lacking plasminogen activator inhibitor 1. J Biol Chem. 2008 May 16;283(20):13538-48. doi: 10.1074/jbc.M709950200. Epub 2008 Mar 22.
PubMed 18359942Zhang HH, Halbleib M, Ahmad F, Manganiello VC, Greenberg AS. Tumor necrosis factor-alpha stimulates lipolysis in differentiated human adipocytes through activation of extracellular signal-related kinase and elevation of intracellular cAMP. Diabetes. 2002 Oct;51(10):2929-35. doi: 10.2337/diabetes.51.10.2929.
PubMed 12351429Laurencikiene J, van Harmelen V, Arvidsson Nordstrom E, Dicker A, Blomqvist L, Naslund E, Langin D, Arner P, Ryden M. NF-kappaB is important for TNF-alpha-induced lipolysis in human adipocytes. J Lipid Res. 2007 May;48(5):1069-77. doi: 10.1194/jlr.M600471-JLR200. Epub 2007 Feb 1.
PubMed 17272828Bocci G, Fioravanti A, Orlandi P, Di Desidero T, Natale G, Fanelli G, Viacava P, Naccarato AG, Francia G, Danesi R. Metronomic ceramide analogs inhibit angiogenesis in pancreatic cancer through up-regulation of caveolin-1 and thrombospondin-1 and down-regulation of cyclin D1. Neoplasia. 2012 Sep;14(9):833-45. doi: 10.1593/neo.12772.
PubMed 23019415
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRUVEDomics Study: Use of a Behavioral Nutrition Intervention in Young Adults to Identify Modifiable Metabolomics and Microbiome Risk
- ClinicalTrials.gov ID
- NCT03115866
- Acronym / sponsor ID
- FRUVEDomics / 1409433435
- Conditions
- Metabolic Syndrome
- Keywords
- Healthy Diet, Fruits and Vegetables, Metabolome, Microbiome, Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- University of Tennessee, University of New Hampshire
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. The purpose of this project is to evaluate the impact of the FRUVEDomics behavior intervention on dietary behaviors and metabolic parameters on young adults "at-risk" of disease. FRUVEDomics is an 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure "risk" status for chronic disease. Subjects were randomized into one of three nutritional intervention groups: 1) "FRUVED" (50% fruit \& vegetable), 2) "FRUVED+LRC" (50% fruit \& vegetable plus low refined carbohydrate), and 3) "FRUVED+LF" (50% fruit \& vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
Detailed description
Background: Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28), further creating a need for interventions that will improve later quality of life. Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. In the past decade, there has been considerable research on behavior interventions focusing on dietary change for the promotion of health. However, successful theory-based dietary behavioral interventions for young adults who follow poor lifestyle habits, are limited. The purpose of this paper is to evaluate the impact of the FRUVEDomics pilot study on dietary behaviors and metabolic parameters on young adults "at-risk" of disease.
Methods: An 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, was conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure "risk" status for chronic disease. Subjects (n=36) were randomized into one of three nutritional intervention groups; 1) "FRUVED" (50% fruit \& vegetable), 2) "FRUVED+LRC" (50% fruit \& vegetable plus low refined carbohydrate), and 3) "FRUVED+LF" (50% fruit \& vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were successfully delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
Specific Aim: Identify novel metabolomic and microbiome phenotypes in response to fruit and vegetable diet intervention in young adults with and without metabolic syndrome (MetS).
Hypothesis 1: Diet consisting of 50% fruit \& vegetable consumption (FRUVED diet) will improve metabolic health as evidenced by lower plasma concentrations of adipokines, inflammatory mediators, and ceramides.
Hypothesis 2. Diet induced changes in the metabolome and micobiome will reveal novel phenotypes that have the potential to be used as new diagnostic biomarkers to distinguish between MetS and healthy adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2 interventions evaluated against the other and a control.
| Arm | Type | Receives |
|---|---|---|
| FRUVED | Experimental | Behavioral: FRUVEDomicsIndividuals that are at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet with 50% fruit and vegetables. |
| FRUVED + LRC | Experimental | Behavioral: FRUVEDomicsIndividuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low refined carbohydrates. |
| FRUVED + LF | Experimental | Behavioral: FRUVEDomicsIndividuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low fat. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 28 years of age
- either showing evidence of metabolic syndrome or at risk for metabolic syndrome
Key exclusion criteria (1 listed)
- no evidence of metabolic syndrome or of being at-risk for metabolic syndrome
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 |
|---|---|---|
| FRUVEDomicsFRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention. | Behavioural | FRUVED, FRUVED + LF, FRUVED + LRC |
Primary outcome
Change in metabolic parameters at 8 weeks
Time frame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
Metabolomic measures via blood sample
4 secondary outcomes
Change in microbiome parameters at 8 weeks
Time frame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
Change in Weight and BMI at 8 weeks
Time frame: 8 weeks
Change in Blood pressure at 8 weeks
Time frame: 8 weeks
Change in Arterial stiffness at 8 weeks
Time frame: 8 weeks
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 19 Sep 2024.
- Background: PubMed 12208856Tabas I. Cholesterol in health and disease. J Clin Invest. 2002 Sep;110(5):583-90. doi: 10.1172/JCI16381. No abstract available.
- Background: PubMed 12154382Barsh GS, Schwartz MW. Genetic approaches to studying energy balance: perception and integration. Nat Rev Genet. 2002 Aug;3(8):589-600. doi: 10.1038/nrg862. No abstract available.
- Background: PubMed 12044392Seeman E. Pathogenesis of bone fragility in women and men. Lancet. 2002 May 25;359(9320):1841-50. doi: 10.1016/S0140-6736(02)08706-8.
- Background: PubMed 23493899Catalan U, Rodriguez MA, Ras MR, Macia A, Mallol R, Vinaixa M, Fernandez-Castillejo S, Valls RM, Pedret A, Griffin JL, Salek R, Correig X, Motilva MJ, Sola R. Biomarkers of food intake and metabolite differences between plasma and red blood cell matrices; a human metabolomic profile approach. Mol Biosyst. 2013 Jun;9(6):1411-22. doi: 10.1039/c3mb25554a. Epub 2013 Mar 14.
- Background: PubMed 12221197German JB, Roberts MA, Fay L, Watkins SM. Metabolomics and individual metabolic assessment: the next great challenge for nutrition. J Nutr. 2002 Sep;132(9):2486-7. doi: 10.1093/jn/132.9.2486. No abstract available.
- Background: PubMed 965540Morrow DA. Fat cow syndrome. J Dairy Sci. 1976 Sep;59(9):1625-9. doi: 10.3168/jds.S0022-0302(76)84415-3.
- Background: PubMed 3905736McCann JP, Reimers TJ. Insulin response to glucose in estrous and diestrous obese and lean heifers. J Anim Sci. 1985 Sep;61(3):619-23. doi: 10.2527/jas1985.613619x.
- Background: PubMed 17167477Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Background: PubMed 18451260Holland WL, Summers SA. Sphingolipids, insulin resistance, and metabolic disease: new insights from in vivo manipulation of sphingolipid metabolism. Endocr Rev. 2008 Jun;29(4):381-402. doi: 10.1210/er.2007-0025. Epub 2008 May 1.
- Background: PubMed 8870666Long SD, Pekala PH. Lipid mediators of insulin resistance: ceramide signalling down-regulates GLUT4 gene transcription in 3T3-L1 adipocytes. Biochem J. 1996 Oct 1;319 ( Pt 1)(Pt 1):179-84. doi: 10.1042/bj3190179.
- Background: PubMed 8626623Kanety H, Hemi R, Papa MZ, Karasik A. Sphingomyelinase and ceramide suppress insulin-induced tyrosine phosphorylation of the insulin receptor substrate-1. J Biol Chem. 1996 Apr 26;271(17):9895-7. doi: 10.1074/jbc.271.17.9895.
- Background: PubMed 18359942Shah C, Yang G, Lee I, Bielawski J, Hannun YA, Samad F. Protection from high fat diet-induced increase in ceramide in mice lacking plasminogen activator inhibitor 1. J Biol Chem. 2008 May 16;283(20):13538-48. doi: 10.1074/jbc.M709950200. Epub 2008 Mar 22.
- Olfert Research LabLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
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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.
Melissa D. Olfert, DrPH, RDN principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A study testing FRUVEDomics in people with Metabolic Syndrome, run by West Virginia University.
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 2 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in metabolic parameters at 8 weeks (time frame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115866, which also lists 27 linked publications.
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 19 Sep 2024.