NCT02213523

ABG Oxidative Stress Study Protocol-1

Proof of Concept Study to Evaluate the Effect of Oxidative Stress Response of Plant Concentrate Blends in Healthy Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Access Business Group · Industry
• Sex: Male
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates.

Detailed description

Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome, cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is associated with protective effects on the investigators health. The strategy to prevent chronic disease development and in making up the nutritional gap in the investigators diet has shifted from vitamins and minerals supplementation to whole foods and whole food products. The objectives is to evaluate the effect of oxidative stress response of plant concentrate blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly, collecting additional information on whether blends of plant concentrate have other potential health benefits. This study will test the dose-response of blends of plant concentrates. Healthy men (n=60) with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be performed.Genes associated with oxidative stress will me monitored. The outcome of this study will help us understand how to design and develop future antioxidant related products.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant concentrate A	Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
DIETARY_SUPPLEMENT	Plant concentrate B	Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
DIETARY_SUPPLEMENT	Plant concentrate C	Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
DIETARY_SUPPLEMENT	Plant concentrate D	Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2013-12-01
• First posted: 2014-08-11
• Last updated: 2014-08-11

Locations

2 sites across 1 country: United States