Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention
SINFONI
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2019
CompletedFirst Posted
Study publicly available on registry
December 9, 2019
CompletedStudy Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2022
CompletedSeptember 25, 2025
September 1, 2025
2.3 years
November 13, 2019
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline, 8 and 9 weeks
Secondary Outcomes (16)
Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin
baseline, 8 and 9 weeks
Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)
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
baseline, 8 and 9 weeks
Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA
baseline, 8 and 9 weeks
Change from baseline body composition
baseline, 8 and 9 weeks
- +11 more secondary outcomes
Study Arms (2)
bioactive components fortified food products
EXPERIMENTALcontrol food products
PLACEBO COMPARATORInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, 69310, France
Related Publications (2)
Hornero-Ramirez H, Morisette A, Marcotte B, Penhoat A, Lecomte B, Panthu B, Lessard Lord J, Thirion F, Van-Den-Berghe L, Blond E, Simon C, Caussy C, Feugier N, Dore J, Sanoner P, Meynier A, Desjardins Y, Pilon G, Marette A, Cani PD, Laville M, Vinoy S, Michalski MC, Nazare JA. Multifunctional dietary approach reduces intestinal inflammation in relation with changes in gut microbiota composition in subjects at cardiometabolic risk: the SINFONI project. Gut Microbes. 2025 Dec;17(1):2438823. doi: 10.1080/19490976.2024.2438823. Epub 2024 Dec 22.
PMID: 39710576BACKGROUNDDemangeat A, Hornero-Ramirez H, Meynier A, Sanoner P, Atkinson FS, Nazare JA, Vinoy S. Complementary Nutritional Improvements of Cereal-Based Products to Reduce Postprandial Glycemic Response. Nutrients. 2023 Oct 17;15(20):4401. doi: 10.3390/nu15204401.
PMID: 37892479BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine LAVILLE, Pr
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2019
First Posted
December 9, 2019
Study Start
January 21, 2020
Primary Completion
May 17, 2022
Study Completion
May 17, 2022
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share