Abdominal Obesity Clinical Trial
— SINFONIOfficial title:
Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention.
Verified date | March 2023 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre de Recherche en Nutrition Humaine Rhône-Alpes | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04940962 -
Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion
|
N/A | |
Completed |
NCT02194504 -
The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
|
N/A | |
Completed |
NCT00374218 -
Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
|
Phase 2 | |
Completed |
NCT00520858 -
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
|
N/A | |
Recruiting |
NCT03212391 -
WAVE Study- Walking and Aging in VErona Study
|
N/A | |
Completed |
NCT03898518 -
The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
|
N/A | |
Recruiting |
NCT04136717 -
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
|
N/A | |
Completed |
NCT05413954 -
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
|
N/A | |
Recruiting |
NCT05062954 -
Effects of a Polyphenol-rich Cranberry Extract on Cardiometabolic and Neurocognitive Health
|
N/A | |
Completed |
NCT01472666 -
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
|
N/A | |
Completed |
NCT00990457 -
Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)
|
Phase 3 | |
Completed |
NCT05685017 -
Adiponectin, ICAM-1, VCAM-1 Levels and Metabolic Syndrome in Obese Adolescents
|
||
Completed |
NCT03773900 -
Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
|
N/A | |
Completed |
NCT04635332 -
Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
|
N/A | |
Completed |
NCT00739180 -
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
|
N/A | |
Completed |
NCT00664729 -
Diet, Exercise, Metabolism, and Obesity in Older Women
|
N/A | |
Completed |
NCT03389425 -
Application of the SIMPLE Program for Weight Loss at Pathways to Housing: A Feasibility Study
|
N/A | |
Completed |
NCT05900843 -
Weight Abnormalities With Diet and Exercise Frequency in Egyptian Children With Cerebral Palsy
|
||
Not yet recruiting |
NCT06376955 -
High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity
|
N/A | |
Recruiting |
NCT05879692 -
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
|
N/A |