NCT03309982

Intestinal Inflammatory and Metabolic Responses to a High Fat Meal and Plant Polyphenol Blend

A Randomized Placebo-controlled Cross-over Design Study Investigating the Effects of a Plant Polyphenol Blend on the Intestinal Inflammatory and Metabolic Responses to a High Fat Meal in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge with a high-fat (HF) meal. The investigators will use a randomized crossover study to investigate the effects of: 1) placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists of English muffin bread, sausage, egg and cheese, obtained from US market and completed with palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. The high-fat meal will be standard and it will not be adjusted for large and small participants.

Conditions

• Anthocyanins

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant polyphenol blend	A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
OTHER	Placebo	A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Timeline

• Start date: 2017-10-16
• Primary completion: 2018-03-27
• Completion: 2018-03-27
• First posted: 2017-10-16
• Last updated: 2018-04-20

Locations

1 site across 1 country: United States