Metabolic SyndromeMetLDINCT03836651
Dietary Intervention in Persons With Metabolic Syndrome
A study testing Dietary Antioxidant (V8® Low Sodium 100% vegetable juice) in people with Metabolic Syndrome, run by Martha Biddle at 1 site in United States.
Trial summary
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 23 Sep 2021
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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. - 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). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dietary Intervention to Reduce Inflammation and Oxidative Stress in Persons With Metabolic Syndrome
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Dietary Antioxidant (V8® Low Sodium 100% vegetable juice), Control group
- Keywords
- oxidative stress, metabolic syndrome, inflammation
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)Other
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Control group |
| Intervention Group | Experimental | 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. Receives: Other: Dietary Antioxidant (V8® Low Sodium 100% vegetable juice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma C-reactive Protein (CRP) from baseline to one month.
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.
Measured: Baseline and one month
Secondary outcomes (1)
Change in plasma Malondialdehyde (MDA) from baseline to one month.
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.
Measured: Baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Dec 2018
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is that of a two-group randomized controlled intervention study. Subjects (N=100) will be randomized to 1 of 2 groups (intervention group or usual care/control group). Subjects will be recruited from outpatient cardiology clinics. The intervention group will be given one 11.5 ounce can of V8® 100% vegetable juice to drink each day for 30 days in addition to their normal diet. The usual care group will continue to consume their normal diet. Data collection for both groups will occur at baseline, and at one-month post-baseline. Data will include sociodemographic and clinical information, 24-hr dietary recalls, carotenoid levels and biomarkers of inflammation and oxidative stress.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martha Biddle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martha Biddle, University of Kentucky
- Investigators
- Martha Biddle, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836651
- Sponsor's protocol ID
- 45582
- Acronym
- MetLDI
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Intervention to Reduce Inflammation and Oxidative Stress in Persons With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03836651
- Acronym / sponsor ID
- MetLDI / 45582
- Conditions
- Metabolic Syndrome
- Keywords
- oxidative stress, metabolic syndrome, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Martha BiddleUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 11 Feb 2019 (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.
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is that of a two-group randomized controlled intervention study. Subjects (N=100) will be randomized to 1 of 2 groups (intervention group or usual care/control group). Subjects will be recruited from outpatient cardiology clinics. The intervention group will be given one 11.5 ounce can of V8® 100% vegetable juice to drink each day for 30 days in addition to their normal diet. The usual care group will continue to consume their normal diet. Data collection for both groups will occur at baseline, and at one-month post-baseline. Data will include sociodemographic and clinical information, 24-hr dietary recalls, carotenoid levels and biomarkers of inflammation and oxidative stress.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control groupFollowing 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. |
| Intervention Group | Experimental | Other: Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)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. | Other | Intervention Group |
| Control groupThe 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. | Other | Control Group |
Primary outcome
Change in plasma C-reactive Protein (CRP) from baseline to one month.
Time frame: Baseline and one month
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.
1 secondary outcome
Change in plasma Malondialdehyde (MDA) from baseline to one month.
Time frame: Baseline and one month
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 10 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Martha Biddle, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Antioxidant (V8® Low Sodium 100% vegetable juice) in people with Metabolic Syndrome, run by Martha Biddle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Mar 2022. 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 United States. 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. 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 plasma C-reactive Protein (CRP) from baseline to one month. (time frame: Baseline and one month). 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 10 Mar 2022.