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Completed

NCT Number: NCT02430064

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low PAMP diet

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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