NCT04190706

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiometabolic Risk
• Abdominal Obesity

Interventions

Type	Name	Description
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)
OTHER	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)

Timeline

• Start date: 2020-01-21
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2019-12-09
• Last updated: 2025-09-25

Locations

1 site across 1 country: France