CompletedNot Applicable

Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention

France62 participantsStarted 2020-01-21

Plain-language 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.

Who can participate

Age range30 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT04190706

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-17