Study title
Foodmix - Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
Template
Intervention/Observation study
title
Foodmix - Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
description
In this study the effects of nutritional compounds were studied in overweight men with a low grade inflammatory status. The effects of 3 different food treatments as compared to a placebo on markers of inflammation and on parameters of glucose and fat metabolism were investigated. The three different food treatments are a food mix (given as supplement) and two yogurts each containing different probiotic strains. The food mix was composed of a mix of nutritional components [resveratrol, green tea extract, -tocopherol, vitamin C, n–3 (omega-3) polyunsaturated fatty acids, and tomato extract], each reported to affect inflammation parameters and (or) anti-oxidant status but different in their -hypothesized-mode of action. The 3 different food treatments were given to 36 healthy overweight men with mildly elevated plasma C-reactive protein concentrations in a double-blind, placebo-controlled, crossover study with 4 treatment periods of 5 wk each. Inflammatory and oxidative stress defense markers were quantified in plasma and urine. Furthermore, 120 plasma proteins, 274 plasma metabolites (lipids, free fatty acids, and polar compounds), and the transcriptomes of peripheral blood mononuclear cells and adipose tissue were quantified. nutritional compounds were studied in overweight men with a low grade inflammatory status.
startDate
2006-12-14 00:00:00.0
Study type
Human Intervention
Objectives
Primary:
To investigate the effects of interventions on anticipated reduction of low-grade inflammatory status by assessing:
1) physiological parameters reflecting inflammation
2) gene expression in relation to inflammation
(a) to identify mechanism of action of the various interventions
(b) to identify possible new candidate biomarkers for inflammatory status.
Secondary:
To investigate the effects of interventions on
(1) parameters of glucose metabolism
(2) parameters related to the expected mechanism of action of treatment compounds, such as antioxidant parameters
Exclusion criteria
chronic disease related to inflammation,
history of medical or surgical events that may significantly affect the study outcome,
High blood pressure (age <55 y: DBP>100 or SBP>160 mm Hg, age 55-59: DBP>90 or SBP>140 mm Hg),
fasting blood glucose>6.9 mmol/L,
fasting cholesterol>8 mmol/L,
blood haemoglobin<8 mmol/L,
use of medication that might interfere with parameters to be measured or with one of the treatments,
frequent use of antibiotic medication > 2x in the past year,
frequent NSAID or paracetamol use,
lactose intolerance,
smoking,
extreme physical exercise>6 hours/week,
reported unexplained weight loss or gain of > 4 kg in the month prior to the pre-study screening,
alcohol consumption>28 units per week,
preported slimming or medically prescribed diet,
recent blood donation (<1 month prior to the start of the study
use of food supplements
use of probiotic containing products
Inclusion criteria
Healthy,
Male 18-<60 y,
BMI 26-35 kg/m2,
CRP 1-10 mg/L,
willing to use the study substances daily for 20 weeks,
normal Dutch eating habits
Institute
TNO Quality of Life, Zeist, The Netherlands
