NCT03836651: MetLDI

Dietary Intervention in Persons With Metabolic Syndrome

Completed NA Last updated 10 March 2022

What this trial tests

NA trial testing Dietary Antioxidant (V8® Low Sodium 100% vegetable juice) in Metabolic Syndrome in 94 participants. Completed in 23 September 2021.

Timeline

1 December 2018

Primary endpoint
23 September 2021

23 September 2021

Quick facts

Lead sponsor	Martha Biddle
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	1 December 2018
Primary completion	23 September 2021
Estimated completion	23 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)
• Control group — full drug profile →

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Martha Biddle

Who can join

Adults 21 to 90, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in Delivering Oxidative Modulators for Disease Therapy.
   Yang W, Yue H, Lu G, Wang W, et al · · 2022 · cited 26× · PMID 39070608 · DOI 10.34133/2022/9897464