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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
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    April 24, 2015
    Last Updated
    April 28, 2015
    Sponsor
    University of Leicester
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    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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