Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention (SINFONI)
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
62 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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