The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

August 10, 2015 updated by: James Hollis, Iowa State University

Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults

The purpose of this study was to determine the effect of different dietary fats (saturated or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial endotoxemia.Participants were recruited via email and randomized to treatment meal in this single-blind, cross-over study. Each test session participants reported to the laboratory right away in the morning. An indwelling catheter was inserted into the participant non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant was then provided with one of four test meals (a porridge-type meal containing a different dietary fat), which they ate in entirety within 15 minutes. The participants remained in the laboratory for the next five and a half hours and were not allowed to consume any food or drink except water. During this time, further blood draws were taken at intervals of one hour for a total of five hours after the consumption of the test meal. Collected blood was processed on-site and the serum fraction collected and tested for endotoxin, inflammatory biomarkers, and metabolites.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Ames, Iowa, United States, 50010
        • Nutrition and Wellness Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 18 and 40 years old;
  • Willingness to eat test meals;
  • Body mass index ≥ 19.9 ±0.8 and ≤ 24.9 ±0.8;
  • Weight stable (< 2 kilogram weight change in the previous 3 months)

Exclusion Criteria:

  • Presence of acute or chronic disease;
  • Use of tobacco products;
  • Consumes more than 21 units of alcohol per week;
  • Use of anti-inflammatory medication;
  • History suggestive of macronutrient malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Meal Saturated Fat
Saturated-fat Treatment Meal
Isocaloric test meal that provided 35% fat with saturated fat (16 g).
Experimental: Test Meal N-6 Fat
N-6 fat Treatment Meal.
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
Experimental: Test Meal N-3 Fat
N-3 fat Treatment Meal.
Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)
Experimental: Test Meal Low-fat
Low-fat Treatment Meal.
Isocaloric test meal that provided 20% fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum endotoxin concentration
Time Frame: Change from baseline every one hour, up to five hours
Change from baseline every one hour, up to five hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of biomarkers of inflammation
Time Frame: Change from baseline every one hour, up to five hours
Change from baseline every one hour, up to five hours
Serum concentration of triglycerides, glucose, and non-esterified fatty acids
Time Frame: Change from baseline every one hour, up to five hours
Change from baseline every one hour, up to five hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James H Hollis, PhD, Iowa State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 14-020
  • 2014-67017-21778 (Other Grant/Funding Number: USDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endotoxemia

Clinical Trials on Saturated-fat Treatment Meal

3
Subscribe