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

Pharmanex1 site in 1 country27 target enrollmentOctober 16, 2017

ConditionsAnthocyanins

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anthocyanins
Sponsor: Pharmanex
Enrollment: 27
Locations: 1
Primary Endpoint: Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 16, 2017

End Date

March 27, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pharmanex

Responsible Party

Principal Investigator

Patricia Oteiza, PhD

Professor

University of California, Davis

Eligibility Criteria

Inclusion Criteria

•Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
•Males and females
•Age between 18 - 35 years inclusive
•Subjects with BMI of 22 - 29.9 kg/m2
•Subjects who agree to discontinue the use of pre- and probiotic and/or polyphenol supplements from 4 weeks prior to the first and through the last study visit
•Subjects who agree to discontinue foods containing anthocyanins (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries, and red wine) for at least 1 week prior to each visit.
•Subjects with no known allergies to study product or components (bilberries, black currants, rice)
•Subjects willing to completely consume high-fat meal and assigned study product
•Subjects willing to consume a similar, low fat/low flavonoid \\dinner the evening before each high-fat meal visit
•Subjects have given voluntary, written, informed consent to participate in the study

Exclusion Criteria

•Age \< 18 or \> 35 years
•BMI \< 22 or \> 29.9 kg/m2
•Vegetarian or other dietary restrictions that would not allow the subject to consume the highfat meal
•Regularly participates in endurance exercise activities (e.g. marathon running, triathlons)
•Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg or systolic blood pressure ≥ 160 mmHg
•Screening serum triglycerides \> 150 mg/dL
•Screening fasting blood glucose \< 50 mg/dL or \> 100 mg/dL
•Current smoker or use of tobacco products within the past year
•Individuals who binge drink (alcohol intake ≥ 5 alcoholic drinks for males or ≥4 alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other)
•Substance abuse or dependence within the prior 60 days.

Outcomes

Primary Outcomes

Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

Time Frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

blood sample collected by venipuncture to measure endotoxin in plasma

Secondary Outcomes

Change from baseline in plasma IL-6 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma GLP-1 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma insulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma GLP-2 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma LDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC IL-1β at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma adiponectin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma total cholesterol at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma HDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma total anthocyanidins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC IL-10 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC IL-12p70 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in fingerstick total cholesterol at 15 minutes post high-fat meal consumption(Baseline, and 15 minutes post high-fat meal consumption)
Change from baseline in plasma ghrelin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma zonulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma total polyphenols at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma total catechins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC TNFa at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC NF-kB at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in fingerstick HDL at 15 minutes post high-fat meal consumption(Baseline, and 15 minutes post high-fat meal consumption)
Change from baseline in fingerstick glucose at 15 minutes post high-fat meal consumption(Baseline, and 15 minutes post high-fat meal consumption)
Change from baseline in plasma GIP at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma leptin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma triglycerides at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in PBMC IL-8 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in plasma glucose at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption(Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption)
Change from baseline in fingerstick triglycerides at 15 minutes post high-fat meal consumption(Baseline, and 15 minutes post high-fat meal consumption)
Change from baseline in fingerstick LDL at 15 minutes post high-fat meal consumption(Baseline, and 15 minutes post high-fat meal consumption)