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Completed

NCT Number: NCT04190706

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.

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Key information

Conditions

Cardiometabolic Risk Abdominal Obesity Bacteremia Body Weight Endotoxemia Infections Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Toxemia

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bioactive components fortified food products intake (biscuits and cookies)

Other

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)

control food products intake (biscuits and cookies)

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SINFONI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2019
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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