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

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Other: Low PAMP diet

• Registration Number: NCT02430064
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Study First Posted: 2015-04-29
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low PAMP diet then high PAMP diet	Low PAMP diet	All subjects on study proceed from 7 days low PAMP diet to 4 days high PAMP diet

Primary Outcome Measures

Name	Time	Method
Serum C-reactive protein and white blood cell counts will be used as markers of inflammation (composite).	up to 11 days after enrollment