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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190706
Recruitment Status : Not yet recruiting
First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cardiometabolic Risk Abdominal Obesity Other: bioactive components fortified food products intake (biscuits and cookies) Other: control food products intake (biscuits and cookies) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention.
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

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)




Primary Outcome Measures :
  1. Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14) [ Time Frame: baseline, 8 and 9 weeks ]
    LBP and CD14 proteins will be measured at time 0, 120 and 300 after test meal intake


Secondary Outcome Measures :
  1. Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin [ Time Frame: baseline, 8 and 9 weeks ]
    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

  2. Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide) [ Time Frame: baseline, 8 and 9 weeks ]
    LPS will be measured at time 0, 60, 120, 180, 240, 300 after test meal intake

  3. 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 [ Time Frame: baseline, 8 and 9 weeks ]
    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

  4. Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA [ Time Frame: baseline, 8 and 9 weeks ]
    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

  5. Change from baseline body composition [ Time Frame: baseline, 8 and 9 weeks ]
    Body composition will be measured by BodPod technique

  6. Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids [ Time Frame: baseline, 8 and 9 weeks ]
    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

  7. Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids [ Time Frame: baseline, 8 and 9 weeks ]
    fasting plasma lipids will be measured before test meal ingestion

  8. Change from baseline resting energy expenditure [ Time Frame: baseline, 8 and 9 weeks ]
    resting metabolic rate will be measured by indirect calorimetry

  9. Change from baseline substrates oxidation [ Time Frame: baseline, 8 and 9 weeks ]
    substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.

  10. Change from baseline gut microbiota composition [ Time Frame: baseline, 8 weeks ]
    gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis

  11. Change from baseline stool consistency [ Time Frame: nine weeks ]
    stool consistency will be measured by Bristol scale and every week during the interventional period

  12. Change from baseline stool frequency [ Time Frame: nine weeks ]
    stool frequency will be measured by questionnaire at baseline and every week during the interventional period

  13. Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting [ Time Frame: nine weeks ]
    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

  14. Change from baseline diet intake [ Time Frame: baseline, 8 and 9 weeks ]
    diet intake will be evaluated by a three days diet survey

  15. Change from baseline fasting plasma zonulin [ Time Frame: baseline, 8 and 9 weeks ]
    comparison of fasting plasma zonulin from baseline

  16. Change from baseline polyphenols urinary concentrations [ Time Frame: baseline, 8 weeks ]
    Comparison of polyphenols urinary concentrations from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190706


Contacts
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Contact: Martine LAVILLE, Pr 4 78 86 29 81 ext +33 martine.laville@univ-lyon1.fr
Contact: Julie-Anne NAZARE, Pr 4 78 86 29 81 ext +33 julie-anne.nazare@univ-lyon1.fr

Locations
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France
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, France, 69310
Contact: Martine LAVILLE, Pr    4 78 86 29 54 ext +33    martine.laville@univ-lyon1.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Martine LAVILLE, Pr Centre de Recherche en Nutrition Humaine Rhône-Alpes

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04190706    
Other Study ID Numbers: 69HCL18_0097
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
inflammation
cardiometabolic risk
endotoxemia
polyphenols
oxidative stress
slow digestible starch
fibers
gut microbiota
nutritional challenge test
Additional relevant MeSH terms:
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Obesity, Abdominal
Inflammation
Pathologic Processes
Obesity
Overnutrition
Nutrition Disorders