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

Not Applicable

Completed

• Conditions: Cardiometabolic Risk; Abdominal Obesity
• Interventions: Other: control food products intake (biscuits and cookies); Other: bioactive components fortified food products intake (biscuits and cookies)

• Registration Number: NCT04190706
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-09
• Study Start: 2020-01-21
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control food products	control food products intake (biscuits and cookies)	-
bioactive components fortified food products	bioactive components fortified food products intake (biscuits and cookies)	-

Primary Outcome Measures

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

Name	Time	Method
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	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
Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin	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
Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)	baseline, 8 and 9 weeks	LPS will be measured at time 0, 60, 120, 180, 240, 300 after test meal intake
Change from baseline substrates oxidation	baseline, 8 and 9 weeks	substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.
Change from baseline stool consistency	nine weeks	stool consistency will be measured by Bristol scale and every week during the interventional period
Change from baseline fasting plasma zonulin	baseline, 8 and 9 weeks	comparison of fasting plasma zonulin from baseline
Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids	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
Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids	baseline, 8 and 9 weeks	fasting plasma lipids will be measured before test meal ingestion
Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting	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
Change from baseline diet intake	baseline, 8 and 9 weeks	diet intake will be evaluated by a three days diet survey
Change from baseline body composition	baseline, 8 and 9 weeks	Body composition will be measured by BodPod technique
Change from baseline stool frequency	nine weeks	stool frequency will be measured by questionnaire at baseline and every week during the interventional period
Change from baseline polyphenols urinary concentrations	baseline, 8 weeks	Comparison of polyphenols urinary concentrations from baseline
Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA	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
Change from baseline resting energy expenditure	baseline, 8 and 9 weeks	resting metabolic rate will be measured by indirect calorimetry
Change from baseline gut microbiota composition	baseline, 8 weeks	gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes; 🇫🇷 Pierre-Bénite, France