An interventional study of bioactive components fortified food products intake (biscuits and cookies) and control food products intake (biscuits and cookies) in Cardiometabolic Risk and Abdominal Obesity, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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.
294 studies on the registry are indexed under Obesity, Abdominal; 45 are open to participants now.
This study's enrollment of 62 is close to the median of 58 across 234 interventional studies indexed under Obesity, Abdominal.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: bioactive components fortified food products intake (biscuits and cookies)
Other: control 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)
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)
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
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
Change from baseline body composition
Body composition will be measured by BodPod technique
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
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
Time frame: baseline, 8 and 9 weeks
Change from baseline resting energy expenditure
resting metabolic rate will be measured by indirect calorimetry
Time frame: baseline, 8 and 9 weeks
Change from baseline substrates oxidation
substrates oxidation will be measured by indirect calorimetry after test meal intake during five hours.
Time frame: baseline, 8 and 9 weeks
Change from baseline gut microbiota composition
gut microbiota composition will be measured by 16S RNA (ribonucleic acid) analysis
Time frame: baseline, 8 weeks
Change from baseline stool consistency
stool consistency will be measured by Bristol scale and every week during the interventional period
Time frame: nine weeks
Change from baseline stool frequency
stool frequency will be measured by questionnaire at baseline and every week during the interventional period
Time frame: nine weeks
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
Time frame: nine weeks
Change from baseline diet intake
diet intake will be evaluated by a three days diet survey
Time frame: baseline, 8 and 9 weeks
Change from baseline fasting plasma zonulin
comparison of fasting plasma zonulin from baseline
Time frame: baseline, 8 and 9 weeks
Change from baseline polyphenols urinary concentrations
Comparison of polyphenols urinary concentrations from baseline
Time frame: baseline, 8 weeks
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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