Clinical trial NCT02430064: Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Official title: Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum C-reactive protein and white blood cell counts will be used as markers of inflammation (composite).
timeFrame: up to 11 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Leicester
name: Clett Erridge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.