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Cardiometabolic RiskSINFONINCT04190706

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

A study testing bioactive components fortified food products intake (biscuits and cookies) in people with Cardiometabolic Risk and Abdominal Obesity, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiometabolic Risk, Abdominal Obesity
What is being tested?
bioactive components fortified food products intake (biscuits and cookies)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteFrance
Study dates
21 Jan 2020to 17 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Centre de Recherche en Nutrition Humaine Rhône-Alpes

    Pierre-Bénite, 69310

Other trials in France

About this study

Official title: 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.

Being tested
bioactive components fortified food products intake (biscuits and cookies), control food products intake (biscuits and cookies)
Keywords
inflammation, cardiometabolic risk, endotoxemia, polyphenols, oxidative stress, slow digestible starch, fibers, gut microbiota, nutritional challenge test
Medical subject headings
Obesity, Abdominal, Inflammation, Endotoxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT04190706
Study groupRoleWhat they receive
bioactive components fortified food productsExperimentalNot described
Receives: Other: bioactive components fortified food products intake (biscuits and cookies)
control food productsPlacebo comparatorNot described
Receives: Other: control food products intake (biscuits and cookies)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, 8 and 9 weeks

Secondary outcomes (16)

  1. 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

    Measured: baseline, 8 and 9 weeks

  2. 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

    Measured: baseline, 8 and 9 weeks

  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

    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

    Measured: baseline, 8 and 9 weeks

  4. 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

    Measured: baseline, 8 and 9 weeks

  5. Change from baseline body composition

    Body composition will be measured by BodPod technique

    Measured: baseline, 8 and 9 weeks

  6. 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

    Measured: baseline, 8 and 9 weeks

  7. 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

    Measured: baseline, 8 and 9 weeks

  8. Change from baseline resting energy expenditure

    resting metabolic rate will be measured by indirect calorimetry

    Measured: baseline, 8 and 9 weeks

  9. Change from baseline substrates oxidation

    substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.

    Measured: baseline, 8 and 9 weeks

  10. Change from baseline gut microbiota composition

    gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis

    Measured: baseline, 8 weeks

  11. Change from baseline stool consistency

    stool consistency will be measured by Bristol scale and every week during the interventional period

    Measured: nine weeks

  12. Change from baseline stool frequency

    stool frequency will be measured by questionnaire at baseline and every week during the interventional period

    Measured: nine weeks

  13. 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

    Measured: nine weeks

  14. Change from baseline diet intake

    diet intake will be evaluated by a three days diet survey

    Measured: baseline, 8 and 9 weeks

  15. Change from baseline fasting plasma zonulin

    comparison of fasting plasma zonulin from baseline

    Measured: baseline, 8 and 9 weeks

  16. Change from baseline polyphenols urinary concentrations

    Comparison of polyphenols urinary concentrations from baseline

    Measured: baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start21 Jan 2020
  3. Primary completion17 May 2022
  4. Study completion17 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190706
Sponsor's protocol ID
69HCL18_0097
Acronym
SINFONI
Status last verified
Sep 2025
First submitted
13 Nov 2019
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39710576

  • Demangeat 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.

    PubMed 37892479

Questions about this trial

What is this clinical trial studying?

A study testing bioactive components fortified food products intake (biscuits and cookies) in people with Cardiometabolic Risk and Abdominal Obesity, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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