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Completed

NCT Number: NCT02521779

The Role of Dietary Fat on Postprandial Endotoxemia 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Wellness Research Center

Ames, Iowa, 50010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-fat Treatment Meal

Other

Isocaloric test meal that provided 20% fat.

Saturated-fat Treatment Meal

Other

Isocaloric test meal that provided 35% fat with saturated fat (16 g).

N-3 fat Treatment Meal

Other

Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)

N-6 fat Treatment Meal

Other

Isocaloric test meal that provided 35% fat with n-6 (7.4 g).

Primary outcomes

  1. Serum endotoxin concentration

    Time frame: Change from baseline every one hour, up to five hours

Secondary outcomes

  1. Serum concentration of biomarkers of inflammation

    Time frame: Change from baseline every one hour, up to five hours

  2. Serum concentration of triglycerides, glucose, and non-esterified fatty acids

    Time frame: Change from baseline every one hour, up to five hours

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Official study title

Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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