NCT02430064

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation

Interventions

Type	Name	Description
OTHER	Low PAMP diet

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-04-29
• Last updated: 2015-04-29