The aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject. The inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
62
Volunteers will have to consume daily 100 g of fortified biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass)
Volunteers will have to consume daily 100 g of standard biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass)
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, France
Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14)
LBP and CD14 proteins will be measured at time 0, 120 and 300 after test meal intake
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin
MCP-1 ( monocyte chemotactic protein-1), RANTES (Regulated on activation, normal T expressed and secreted), IFNγ (Interferon γ) , IL-6 (Interleukin 6), TNF-α (Tumor Necrosis Factor α), IL-1β (Interleukin 1β), CRPus, adiponectin will be measured at time 0 and 300 minutes after test meal intake
Time frame: baseline, 8 and 9 weeks
Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)
LPS will be measured at time 0, 60, 120, 180, 240, 300 after test meal intake
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting and postprandial plasma endothelial function markers: Human CVD Panel 2, Lipocalin-2/NGAL, Myeloperoxidase, sICAM-1, sVCAM-1, ADAMTS13, D-dimer, GDF-15, Myoglobin, sP-Selectin, Serum Amyloid A
Human CVD Panel 2, Lipocalin-2/NGAL (neutrophil gelatinase-associated lipocalin), Myeloperoxidase, sICAM-1(Soluble Inter-cellular Adhesion Molecule-1), sVCAM-1(Soluble Form of Vascular Cell Adhesion Molecule 1), ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13), D-dimer, GDF-15 (Growth differentiation factor 15), Myoglobin, sP-Selectin, Serum Amyloid A will be measured at time 0 and 300 minutes after test meal intake
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA
GSH (glutathione), GSSG (glutathione disulfide), Glutathion peroxidase/ reductase activity will be measured at time 0 and MDA (malondialdehyde) will be measured at 0 and 300 minutes after test meal intake
Time frame: baseline, 8 and 9 weeks
Change from baseline body composition
Body composition will be measured by BodPod technique
Time frame: baseline, 8 and 9 weeks
Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids
Plasma metabolites and hormone will be measured at time -30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes after test meal intake
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids
fasting plasma lipids will be measured before test meal ingestion
Time frame: baseline, 8 and 9 weeks
Change from baseline resting energy expenditure
resting metabolic rate will be measured by indirect calorimetry
Time frame: baseline, 8 and 9 weeks
Change from baseline substrates oxidation
substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.
Time frame: baseline, 8 and 9 weeks
Change from baseline gut microbiota composition
gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis
Time frame: baseline, 8 weeks
Change from baseline stool consistency
stool consistency will be measured by Bristol scale and every week during the interventional period
Time frame: nine weeks
Change from baseline stool frequency
stool frequency will be measured by questionnaire at baseline and every week during the interventional period
Time frame: nine weeks
Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting
Gastro intestinal symptoms will be collected by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum)) at baseline and every week during the interventional period
Time frame: nine weeks
Change from baseline diet intake
diet intake will be evaluated by a three days diet survey
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting plasma zonulin
comparison of fasting plasma zonulin from baseline
Time frame: baseline, 8 and 9 weeks
Change from baseline polyphenols urinary concentrations
Comparison of polyphenols urinary concentrations from baseline
Time frame: baseline, 8 weeks
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