EndotoxemiaNCT02521779
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults
A study testing Low-fat Treatment Meal, Saturated-fat Treatment Meal and N-3 fat Treatment Meal in people with Endotoxemia, run by Iowa State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia
- What is being tested?
- Low-fat Treatment Meal, Saturated-fat Treatment Meal and N-3 fat Treatment Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition and Wellness Research Center
Ames, Iowa, 50010
About this study
Official title: 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.
- Conditions
- Endotoxemia
- Being tested
- Low-fat Treatment Meal, Saturated-fat Treatment Meal, N-3 fat Treatment Meal, N-6 fat Treatment Meal
- Keywords
- Inflammation, Endotoxemia, Lipopolysaccharide, Diet, Fat, Postprandial
- Medical subject headings
- Endotoxemia, Inflammation, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat Treatment MealOther
Isocaloric test meal that provided 20% fat.
Saturated-fat Treatment MealOther
Isocaloric test meal that provided 35% fat with saturated fat (16 g).
N-3 fat Treatment MealOther
Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)
N-6 fat Treatment MealOther
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
| Study group | Role | What they receive |
|---|---|---|
| Test Meal Saturated Fat | Experimental | Saturated-fat Treatment Meal Receives: Other: Saturated-fat Treatment Meal |
| Test Meal N-6 Fat | Experimental | N-6 fat Treatment Meal. Receives: Other: N-6 fat Treatment Meal |
| Test Meal N-3 Fat | Experimental | N-3 fat Treatment Meal. Receives: Other: N-3 fat Treatment Meal |
| Test Meal Low-fat | Experimental | Low-fat Treatment Meal. Receives: Other: Low-fat Treatment Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum endotoxin concentration
Measured: Change from baseline every one hour, up to five hours
Secondary outcomes (2)
Serum concentration of biomarkers of inflammation
Measured: Change from baseline every one hour, up to five hours
Serum concentration of triglycerides, glucose, and non-esterified fatty acids
Measured: Change from baseline every one hour, up to five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndotoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Hollis, Iowa State University
- Investigators
- James H Hollis, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521779
- Sponsor's protocol ID
- 14-020
- Other IDs
- 2014-67017-21778, 2014
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17991637Fritsche 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.
PubMed 25979502Mani 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.
PubMed 23305038Lyte 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.
PubMed 27816052
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults
- ClinicalTrials.gov ID
- NCT02521779
- Acronym / sponsor ID
- 14-020
- Conditions
- Endotoxemia
- Keywords
- Inflammation, Endotoxemia, Lipopolysaccharide, Diet, Fat, Postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Meal Saturated Fat | Experimental | Other: Saturated-fat Treatment MealSaturated-fat Treatment Meal |
| Test Meal N-6 Fat | Experimental | Other: N-6 fat Treatment MealN-6 fat Treatment Meal. |
| Test Meal N-3 Fat | Experimental | Other: N-3 fat Treatment MealN-3 fat Treatment Meal. |
| Test Meal Low-fat | Experimental | Other: Low-fat Treatment MealLow-fat Treatment Meal. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat Treatment MealIsocaloric test meal that provided 20% fat. | Other | Test Meal Low-fat |
| Saturated-fat Treatment MealIsocaloric test meal that provided 35% fat with saturated fat (16 g). | Other | Test Meal Saturated Fat |
| N-3 fat Treatment MealIsocaloric test meal that provided 35% fat with n-3 (DHA = 500mg) | Other | Test Meal N-3 Fat |
| N-6 fat Treatment MealIsocaloric test meal that provided 35% fat with n-6 (7.4 g). | Other | Test Meal N-6 Fat |
Primary outcome
Serum endotoxin concentration
Time frame: Change from baseline every one hour, up to five hours
2 secondary outcomes
Serum concentration of biomarkers of inflammation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 17991637Erridge 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.
- Background: PubMed 25979502Fritsche 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.
- Background: PubMed 23305038Mani 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.
- Derived from this study: PubMed 27816052Lyte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James H Hollis, PhD principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat Treatment Meal, Saturated-fat Treatment Meal and N-3 fat Treatment Meal in people with Endotoxemia, run by Iowa State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum endotoxin concentration (time frame: Change from baseline every one hour, up to five hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521779, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.