Clinical trial NCT04190706: Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention
Official title: Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Abdominal Obesity
Keywords: inflammation
cardiometabolic risk
endotoxemia
polyphenols
oxidative stress
slow digestible starch
fibers
gut microbiota
nutritional challenge test
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Body Mass Index of 25 to 35 kg/m2
* Waist circumference greater than 80 cm for women and than 96 cm for men
* Daily biscuits consumption
* Fibers intake \<25g/day

Exclusion Criteria:

* Medical history of digestive surgery or disease
* Large polyphenols food products consumer (cranberries, red berries, coffee, tea, red wine, fruits and vegetables...)
* Current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
* Current probiotics, prebiotics, fibers complement, and/or any products modulation gut transit
* Feeding particular diet such as vegetarian diet or hyperprotein diet
* Current weight loss diet
* Pregnant or lactating woman or woman who did not use effective contraception
* Drinking more than 3 glasses of alcohol per day (\>30g/day)
* Smoking more than 5 cigarettes per day

Primary outcomes:
measure: Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14)
timeFrame: baseline, 8 and 9 weeks
Secondary outcomes:
measure: Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin
timeFrame: baseline, 8 and 9 weeks
measure: Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)
timeFrame: baseline, 8 and 9 weeks
measure: 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
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline body composition
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline resting energy expenditure
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline substrates oxidation
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline gut microbiota composition
timeFrame: baseline, 8 weeks
measure: Change from baseline stool consistency
timeFrame: nine weeks
measure: Change from baseline stool frequency
timeFrame: nine weeks
measure: Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting
timeFrame: nine weeks
measure: Change from baseline diet intake
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline fasting plasma zonulin
timeFrame: baseline, 8 and 9 weeks
measure: Change from baseline polyphenols urinary concentrations
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study officials:
affiliation: Centre de Recherche en Nutrition Humaine Rhône-Alpes
name: Martine LAVILLE, Pr
role: PRINCIPAL_INVESTIGATOR
References: