Dietary Intervention in Persons With Metabolic Syndrome

NCT03836651 | Completed

• 1 other identifier: 45582
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolic Syndrome

Keywords

oxidative stress; metabolic syndrome; inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and one month

Secondary Outcomes (1)

• Change in plasma Malondialdehyde (MDA) from baseline to one month.

  Baseline and one month

Other Outcomes (2)

• Diet quality: Healthy Eating Index score

  up to 30 days

• Change in skin tissue Carotenoid levels at baseline and 1 month.

  Baseline and one month

Study Arms (2)

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.

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.

Other: Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)

Interventions

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.

Intervention Group

Control group OTHER

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.

Control Group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Martha Biddle: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Interventions

Fruit and Vegetable Juices; Control Groups

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Martha Biddle, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 11, 2019
• Study Start: December 1, 2018
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)