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

NCT03309982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-04-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pharmanex

    lead INDUSTRY

Principal Investigators

  • Patricia Oteiza, PhD · UC Davis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309982 on ClinicalTrials.gov