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

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

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 Overview

• Status: Completed
• Conditions: Cardiometabolic Risk; Abdominal Obesity
• Intervention / Treatment: Other: bioactive components fortified food products intake (biscuits and cookies); Other: control food products intake (biscuits and cookies)

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine LAVILLE, Pr; Phone Number: +33 4 78 86 29 81; Email: martine.laville@univ-lyon1.fr
• Study Contact Backup: Name: Julie-Anne NAZARE, Pr; Phone Number: +33 4 78 86 29 81; Email: julie-anne.nazare@univ-lyon1.fr

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes
    • Contact: Martine LAVILLE, Pr; Phone Number: +33 4 78 86 29 54; Email: martine.laville@univ-lyon1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bioactive components fortified food products	Other: bioactive components fortified food products intake (biscuits and cookies); 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)
Placebo Comparator: control food products	Other: control food products intake (biscuits and cookies); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	baseline, 8 and 9 weeks
Change from baseline body composition	Body composition will be measured by BodPod technique	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	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	baseline, 8 and 9 weeks
Change from baseline resting energy expenditure	resting metabolic rate will be measured by indirect calorimetry	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.	baseline, 8 and 9 weeks
Change from baseline gut microbiota composition	gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis	baseline, 8 weeks
Change from baseline stool consistency	stool consistency will be measured by Bristol scale and every week during the interventional period	nine weeks
Change from baseline stool frequency	stool frequency will be measured by questionnaire at baseline and every week during the interventional period	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	nine weeks
Change from baseline diet intake	diet intake will be evaluated by a three days diet survey	baseline, 8 and 9 weeks
Change from baseline fasting plasma zonulin	comparison of fasting plasma zonulin from baseline	baseline, 8 and 9 weeks
Change from baseline polyphenols urinary concentrations	Comparison of polyphenols urinary concentrations from baseline	baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: inflammation; oxidative stress; gut microbiota; polyphenols; cardiometabolic risk; endotoxemia; slow digestible starch; fibers; nutritional challenge test
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Obesity; Inflammation; Obesity, Abdominal
• Other Study ID Numbers: 69HCL18_0097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No