Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low PAMP diet
Sponsored by

About this trial
This is an interventional basic science trial for Inflammation
Eligibility Criteria
Inclusion Criteria:
- Healthy male consenting volunteers
- Age 18-60
Exclusion Criteria:
- Any existing inflammatory condition, such as chronic kidney disease, inflammatory bowel disease, coronary artery disease or rheumatoid arthritis
- Evidence of an infection within the last two weeks
- Users of prescription medications
- Vaccination within the last two weeks
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low PAMP diet then high PAMP diet
Arm Description
All subjects on study proceed from 7 days low PAMP diet to 4 days high PAMP diet
Outcomes
Primary Outcome Measures
Serum C-reactive protein and white blood cell counts will be used as markers of inflammation (composite).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02430064
Brief Title
Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Official Title
Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leicester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the effects of diets enriched or depleted in foods at high risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7 days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease risk are measured at the start and end of each dietary phase. The aim is to gain an improved understanding of how processed foods modify risk of cardiometabolic disease.
Detailed Description
This study aims to investigate the effects of diets enriched or depleted in foods at high risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7 days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease risk are measured at the start and end of each dietary phase. The aim is to gain an improved understanding of how processed foods modify risk of cardiometabolic disease.
Three blood samples, each of 15 ml, will be taken on days 0, 8 and 12. Measurements at each timepoint include weight, waistline, serum low-density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, insulin, leptin, C-reactive protein and endotoxin.
Volunteers will be requested to avoid processed foods, ready-prepared meals, foods containing minced meats, foods containing ready-chopped vegetables, cheese or chocolate for the first 7 days of the study.
For days 8 to 11, volunteers will be provided with meals, purchased from local supermarkets, which from previous tested were found to contain high levels of bacterial pro-inflammatory molecules (PAMPs).
Diet diaries collected during the study will be combined with diet recall information to investigate habitual and on-study frequency of consumption of specific food groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low PAMP diet then high PAMP diet
Arm Type
Experimental
Arm Description
All subjects on study proceed from 7 days low PAMP diet to 4 days high PAMP diet
Intervention Type
Other
Intervention Name(s)
Low PAMP diet
Primary Outcome Measure Information:
Title
Serum C-reactive protein and white blood cell counts will be used as markers of inflammation (composite).
Time Frame
up to 11 days after enrollment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male consenting volunteers
Age 18-60
Exclusion Criteria:
Any existing inflammatory condition, such as chronic kidney disease, inflammatory bowel disease, coronary artery disease or rheumatoid arthritis
Evidence of an infection within the last two weeks
Users of prescription medications
Vaccination within the last two weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clett Erridge, PhD
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26803597
Citation
Herieka M, Faraj TA, Erridge C. Reduced dietary intake of pro-inflammatory Toll-like receptor stimulants favourably modifies markers of cardiometabolic risk in healthy men. Nutr Metab Cardiovasc Dis. 2016 Mar;26(3):194-200. doi: 10.1016/j.numecd.2015.12.001. Epub 2015 Dec 19.
Results Reference
derived
Learn more about this trial
Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
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