NCT03496584

Effects of Phytonutrients on Vascular Health and Skin in Obese Males

Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will determine the effects of beneficial compounds of plant foods, such as pomegranate on cardiovascular health, skin inflammation and aging. This will be tested by asking healthy males to eat a high fat ground beef patty with 8oz. pomegranate juice or 8oz placebo (a study product that looks like pomegranate juice, but contains no active ingredients) and then measuring blood vessel dilation (endothelial function) by blood flow. The investigators also will measure the amount of Nitric Oxide (NO) in blood and urine samples and sugar and insulin in blood. In addition, a Cutometer, a device that measures the elasticity of the skin, will be used to obtain measurements of skin inflammation and aging. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial plant foods can have on cardiovascular function and the skin.

Detailed description

The proposed investigation has two major objectives: 1. to determine the clinical efficacy of pomegranate juice to reduce skin aging by assessing UV-induced change and skin biological characteristics of elasticity, sebum, hydration/moisture and systemic inflammation and 2. To determine the impact of pomegranate polyphenols on the metabolic response to a high fat meal by postprandial flow-mediated dilation and plasma nitric oxide. The investigators propose to achieve the following specific aims in a randomized, two arm, parallel intervention of pomegranate juice or placebo for 12 weeks in obese men.

Conditions

• Erythema
• Inflammation

Interventions

Type	Name	Description
OTHER	Pomegranate Juice	After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of pomegranate juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.
OTHER	Placebo Juice	After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of placebo juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.

Timeline

• Start date: 2018-03-29
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2018-04-12
• Last updated: 2021-04-19

Locations

1 site across 1 country: United States