Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men

NCT02430064 | Completed

• 1 other identifier: CE01
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Serum C-reactive protein and white blood cell counts will be used as markers of inflammation (composite).

  up to 11 days after enrollment

Study Arms (1)

Low PAMP diet then high PAMP diet

EXPERIMENTAL

All subjects on study proceed from 7 days low PAMP diet to 4 days high PAMP diet

Other: Low PAMP diet

Interventions

Low PAMP diet OTHER

Low PAMP diet then high PAMP diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male consenting volunteers
• Age 18-60

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Related Publications (1)

• 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.

  PMID: 26803597 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clett Erridge, PhD

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04