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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02430064
Enrollment
16
Registered
2015-04-29
Start date
2014-11-30
Completion date
2015-04-30
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

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.

Interventions

OTHERLow PAMP diet

Sponsors

University of Leicester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026