The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

NCT ID: NCT02521779

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endotoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Meal Saturated Fat

Saturated-fat Treatment Meal

Group Type EXPERIMENTAL

Saturated-fat Treatment Meal

Intervention Type OTHER

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

Test Meal N-6 Fat

N-6 fat Treatment Meal.

Group Type EXPERIMENTAL

N-6 fat Treatment Meal

Intervention Type OTHER

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

Test Meal N-3 Fat

N-3 fat Treatment Meal.

Group Type EXPERIMENTAL

N-3 fat Treatment Meal

Intervention Type OTHER

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

Test Meal Low-fat

Low-fat Treatment Meal.

Group Type EXPERIMENTAL

Low-fat Treatment Meal

Intervention Type OTHER

Isocaloric test meal that provided 20% fat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-fat Treatment Meal

Isocaloric test meal that provided 20% fat.

Intervention Type OTHER

Saturated-fat Treatment Meal

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

Intervention Type OTHER

N-3 fat Treatment Meal

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

Intervention Type OTHER

N-6 fat Treatment Meal

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Iowa State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James Hollis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James H Hollis, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nutrition and Wellness Research Center

Ames, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Erridge C, Attina T, Spickett CM, Webb DJ. A high-fat meal induces low-grade endotoxemia: evidence of a novel mechanism of postprandial inflammation. Am J Clin Nutr. 2007 Nov;86(5):1286-92. doi: 10.1093/ajcn/86.5.1286.

Reference Type BACKGROUND
PMID: 17991637 (View on PubMed)

Fritsche KL. The science of fatty acids and inflammation. Adv Nutr. 2015 May 15;6(3):293S-301S. doi: 10.3945/an.114.006940. Print 2015 May.

Reference Type BACKGROUND
PMID: 25979502 (View on PubMed)

Mani V, Hollis JH, Gabler NK. Dietary oil composition differentially modulates intestinal endotoxin transport and postprandial endotoxemia. Nutr Metab (Lond). 2013 Jan 10;10(1):6. doi: 10.1186/1743-7075-10-6.

Reference Type BACKGROUND
PMID: 23305038 (View on PubMed)

Lyte JM, Gabler NK, Hollis JH. Postprandial serum endotoxin in healthy humans is modulated by dietary fat in a randomized, controlled, cross-over study. Lipids Health Dis. 2016 Nov 5;15(1):186. doi: 10.1186/s12944-016-0357-6.

Reference Type DERIVED
PMID: 27816052 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-67017-21778

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Meal Macronutrients on Postprandial Lipids
NCT07313787 NOT_YET_RECRUITING PHASE2