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

NCT03309982 | Completed

• 1 other identifier: 17-PHX-0002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Anthocyanins

Outcome Measures

Primary Outcomes (1)

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

  blood sample collected by venipuncture to measure endotoxin in plasma

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

Secondary Outcomes (28)

• 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 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-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 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 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

Study Arms (2)

Plant polyphenol blend

EXPERIMENTAL

The study product (4 g) consists of 3 g of a mix a maltodextrins, and 1 g of anthocyanin-rich plant polyphenol blend containing: 1) 100 mg bilberry extract; 2) 300 mg black currant extract; and 3) 600 mg black rice extract.

Dietary Supplement: Plant polyphenol blend

Placebo

PLACEBO COMPARATOR

The placebo (4 g) consists of a mix of maltodextrins (3.85 g) and Red Dye No. 40 (0.125 g) and Blue Dye No. 1 (0.025 g).

Other: Placebo

Interventions

Plant polyphenol blend DIETARY_SUPPLEMENT

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Plant polyphenol blend

Placebo OTHER

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Daily use of anti-inflammatory medications including NSAIDs and aspirin in the last 4 weeks
• Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
• History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism in the last 4 weeks
• History of stroke, hepatic, kidney, thyroid disease or cancer
• History of immune related disorders or Raynaud's disease

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

UC Davis Nutrition Department

Davis, California, 95616, United States

Location

Study Officials

• Patricia Oteiza, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized placebo-controlled cross-over design study

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 16, 2017
• Study Start: October 16, 2017
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)