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

Primary Purpose

Cardiometabolic Risk, Abdominal Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

bioactive components fortified food products intake (biscuits and cookies)

control food products intake (biscuits and cookies)

About this trial

This is an interventional basic science trial for Cardiometabolic Risk focused on measuring inflammation, cardiometabolic risk, endotoxemia, polyphenols, oxidative stress, slow digestible starch, fibers, gut microbiota, nutritional challenge test

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bioactive components fortified food products

control food products

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Change from baseline body composition

Body composition will be measured by BodPod technique

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

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

Change from baseline resting energy expenditure

resting metabolic rate will be measured by indirect calorimetry

Change from baseline substrates oxidation

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

Change from baseline gut microbiota composition

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

Change from baseline stool consistency

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

Change from baseline stool frequency

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

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

Change from baseline diet intake

diet intake will be evaluated by a three days diet survey

Change from baseline fasting plasma zonulin

comparison of fasting plasma zonulin from baseline

Change from baseline polyphenols urinary concentrations

Comparison of polyphenols urinary concentrations from baseline

Full Information

NCT ID

NCT04190706

First Posted

November 13, 2019

Last Updated

March 13, 2023

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04190706

Brief Title

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

Acronym

SINFONI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

May 17, 2022 (Actual)

Study Completion Date

May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiometabolic Risk, Abdominal Obesity

Keywords

inflammation, cardiometabolic risk, endotoxemia, polyphenols, oxidative stress, slow digestible starch, fibers, gut microbiota, nutritional challenge test

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bioactive components fortified food products

Arm Type

Experimental

Arm Title

control food products

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

bioactive components fortified food products intake (biscuits and cookies)

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

control food products intake (biscuits and cookies)

Intervention Description

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 Measure Information:

Title

Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14)

Description

LBP and CD14 proteins will be measured at time 0, 120 and 300 after test meal intake

Time Frame

baseline, 8 and 9 weeks

Secondary Outcome Measure Information:

Title

Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin

Description

Time Frame

baseline, 8 and 9 weeks

Title

Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)

Description

LPS will be measured at time 0, 60, 120, 180, 240, 300 after test meal intake

Time Frame

baseline, 8 and 9 weeks

Title

Description

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA

Description

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline body composition

Description

Body composition will be measured by BodPod technique

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids

Description

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

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids

Description

fasting plasma lipids will be measured before test meal ingestion

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline resting energy expenditure

Description

resting metabolic rate will be measured by indirect calorimetry

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline substrates oxidation

Description

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

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline gut microbiota composition

Description

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

Time Frame

baseline, 8 weeks

Title

Change from baseline stool consistency

Description

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

Time Frame

nine weeks

Title

Change from baseline stool frequency

Description

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

Time Frame

nine weeks

Title

Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting

Description

Time Frame

nine weeks

Title

Change from baseline diet intake

Description

diet intake will be evaluated by a three days diet survey

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline fasting plasma zonulin

Description

comparison of fasting plasma zonulin from baseline

Time Frame

baseline, 8 and 9 weeks

Title

Change from baseline polyphenols urinary concentrations

Description

Comparison of polyphenols urinary concentrations from baseline

Time Frame

baseline, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martine LAVILLE, Pr

Organizational Affiliation

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de Recherche en Nutrition Humaine Rhône-Alpes

City

Pierre-Bénite

ZIP/Postal Code

69310

Country

France

12. IPD Sharing Statement

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

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