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

Abdominal Obesity Clinical Trial

— SINFONI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190706
• Other study ID #: 69HCL18_0097
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: May 17, 2022

Study information

• Verified date: March 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Cardiometabolic Risk
• Inflammation
• Obesity, Abdominal

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, 8 and 9 weeks
Secondary	Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFN?, IL-6, TNF-a, IL-1ß, CRPus, adiponectin	MCP-1 ( monocyte chemotactic protein-1), RANTES (Regulated on activation, normal T expressed and secreted), IFN? (Interferon ?) , IL-6 (Interleukin 6), TNF-a (Tumor Necrosis Factor a), IL-1ß (Interleukin 1ß), CRPus, adiponectin will be measured at time 0 and 300 minutes after test meal intake	baseline, 8 and 9 weeks
Secondary	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	baseline, 8 and 9 weeks
Secondary	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	baseline, 8 and 9 weeks
Secondary	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	baseline, 8 and 9 weeks
Secondary	Change from baseline body composition	Body composition will be measured by BodPod technique	baseline, 8 and 9 weeks
Secondary	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	baseline, 8 and 9 weeks
Secondary	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	baseline, 8 and 9 weeks
Secondary	Change from baseline resting energy expenditure	resting metabolic rate will be measured by indirect calorimetry	baseline, 8 and 9 weeks
Secondary	Change from baseline substrates oxidation	substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.	baseline, 8 and 9 weeks
Secondary	Change from baseline gut microbiota composition	gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis	baseline, 8 weeks
Secondary	Change from baseline stool consistency	stool consistency will be measured by Bristol scale and every week during the interventional period	nine weeks
Secondary	Change from baseline stool frequency	stool frequency will be measured by questionnaire at baseline and every week during the interventional period	nine weeks
Secondary	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	nine weeks
Secondary	Change from baseline diet intake	diet intake will be evaluated by a three days diet survey	baseline, 8 and 9 weeks
Secondary	Change from baseline fasting plasma zonulin	comparison of fasting plasma zonulin from baseline	baseline, 8 and 9 weeks
Secondary	Change from baseline polyphenols urinary concentrations	Comparison of polyphenols urinary concentrations from baseline	baseline, 8 weeks