- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03836651
Dietary Intervention in Persons With Metabolic Syndrome (MetLDI)
A Dietary Intervention to Reduce Inflammation and Oxidative Stress in Persons With Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SPECIFIC AIMS An estimated 47 million Americans have been diagnosed with metabolic syndrome. Glucose intolerance, abdominal obesity, hypertension and abnormal lipid profile are the identified traits of metabolic syndrome. Metabolic syndrome is a grouping of conditions that collectively are associated with a two-fold risk of cardiovascular disease (CVD). Inflammation and oxidative stress are contributing factors for the development of atherosclerotic plaque in CVD and are the initial pathological responses for each of the abnormal conditions associated with metabolic syndrome. Consequently, reducing inflammation and oxidative stress are considered appropriate targets for interventions designed for primary prevention of CVD and metabolic syndrome. Primary prevention is the fundamental strategy to reduce cardiovascular mortality. Given the high mortality rate associated with CVD and its vast impact on healthcare expenditures, it is imperative that the investigators develop novel interventions for primary prevention of CVD in persons with metabolic syndrome.
Interventions designed to address primary prevention are considered to be the most effective and logical strategy to improve health before the devastating burden of CVD becomes evident. There is an arsenal of CVD treatment modalities available today with many pharmacologic interventions, however, these come at an enormous cost to individuals and to our healthcare system. To address a gap in the treatment of CVD, nonpharmacologic interventions provide an alternative strategy without expense or undesirable adverse side effects. Simple, inexpensive dietary interventions can have a significant impact on an individual's health and are often overlooked by mainstream healthcare providers because of their simplicity. The impact of increasing fruit and vegetables, which are loaded with antioxidants, into a dietary pattern has consistently been supported in research and is recommended in all primary prevention guidelines. Yet, nine out of ten Americans get less than the recommended amounts of fruits and vegetables in their diet.
The purpose of this study is to test the effect of a dietary antioxidant intervention on inflammation and oxidative stress in individuals with metabolic syndrome. The study has the potential to reduce the incidence of cardiovascular disease. This proposal will address a major goal of Healthy People 2020: Improving cardiovascular health through prevention, detection, and treatment, specifically addressing primary prevention of CVD in individuals with metabolic syndrome.
Specific Aim #1: To test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in individuals who have metabolic syndrome.
Hypothesis #1: Compared to a usual care control group and to their own baseline, individuals randomized to a dietary antioxidant intervention (30-day intake of V8® 100% Low-Sodium Vegetable juice) group will have lower levels of C-reactive protein (CRP) and malondialdehyde (MDA) at one month from baseline. CRP is a biomarker of inflammation and is an independent predictor of cardiovascular disease. MDA is the most prevalent byproduct of lipid peroxidation during oxidative stress and is considered an excellent measurement for use in clinical trials to evaluate oxidative stress.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Subjects will be individuals who have a diagnosis of metabolic syndrome without overt CVD as defined by the National Cholesterol Education Program (NCEP) as evidenced by having at least 3 of the 5 following conditions:
- Hypertension defined as SBP >130mmHg and diastolic >85mmHg
- Abdominal obesity with a waist circumference greater than 88cm in women and greater than 102 cm in men
- Triglycerides level greater than 150mg/dL
- HDL levels less than 50mg/dL in women and less than 40mg/dL in men
Fasting glucose level greater than 100mg/dL Additional inclusion criteria include the ability to read and speak English, and have no cognitive impairment that precludes giving informed consent or ability to follow protocol instructions.
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Exclusion Criteria: Subjects will be excluded from the study if they: a) are less than 21 years of age; b) have a terminal illness; c) have impaired cognition; d) have a strong dislike, or have a potential food-drug interaction to V8® Low Sodium 100% vegetable juice; or e) co-existing illness documented in the medical record or self-reported associated with systemic inflammation (e.g. rheumatoid arthritis, acute systemic infection).
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Control Group
Following completion of baseline data collection, participants will be randomized to one of two groups.
The research assistant will open a pre-assigned envelope in which group assignment was determined by a random number/block generator.
The intervention is designed to complement guideline directed medical management.
Therefore, both the intervention and control group will continue to be medically managed by their health care provider as usual.
In order to avoid introducing the confound of extra attention paid to the intervention group, the control group will have the same visit and call schedule as the intervention group.
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The control group will continue to be medically managed by their health care provider as usual.
The control group will have the same visit and call schedule as the intervention group.
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Experimental: Intervention Group
Following completion of baseline data collection, participants will be randomized to one of two groups.
Participants assigned to the intervention group will receive dietary antioxidants as V8® Low Sodium 100% vegetable juice.
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Following completion of baseline data collection, participants will be randomized to one of two groups.
Participants randomized to the intervention group will receive a month's supply of the V8® 100% Low-Sodium Vegetable juice as the dietary antioxidant intervention.
Participants will be asked to drink one V8® juice each day for 30 days.
Each V8® juice can is 11.5 ounces and can be consumed in divided amounts or all at once.
The average daily intake of lycopene is estimated to be 5mg, one can of V8 juice provides 24 mg of lycopene.
Thirty days duration for the intervention of V8® juice is based on previous data that indicates plasma antioxidant concentrations rise significantly within a two-week period and a plateau effect is reached within 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in plasma C-reactive Protein (CRP) from baseline to one month.
Time Frame: Baseline and one month
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Plasma will be collected at baseline and one month (up to 30 days) later for analysis of CRP.
Data will be presented as the change over time between groups.
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Baseline and one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in plasma Malondialdehyde (MDA) from baseline to one month.
Time Frame: Baseline and one month
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Plasma will be collected at baseline and one month (up to 30 days) later for analysis of MDA.
Data will be presented as the change over time between groups.
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Baseline and one month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Diet quality: Healthy Eating Index score
Time Frame: up to 30 days
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The 24-hour dietary recall will be collected at baseline, two weeks into the study and one month (about 30 days) after study initiation by phone call. Each food recall time point will be analyzed using the Nutrition Data System for Research (NDSR) software program and used to measure diet quality. The food quality assessment will be presented as the change in dietary quality (Healthy Eating Index score) over time between groups. |
up to 30 days
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Change in skin tissue Carotenoid levels at baseline and 1 month.
Time Frame: Baseline and one month
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Skin carotenoid levels will be measured at baseline and 1 month (up to 30 days) using reflection spectroscopy approach (Veggie Meter) to determine adherence to the dietary intervention.
Carotenoid levels will be presented as the change over time between groups.
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Baseline and one month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha Biddle, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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