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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2022-05-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

NCT02192047

Overweight

COMPLETED NA

Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute

NCT03866720

Postprandial Metabolism Appetite

COMPLETED NA

An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects

NCT02148653

Metabolic Syndrome Insulin Resistance Overweight

COMPLETED NA

Effects of Advanced Glycation Endproducts on Satiety and Inflammation

NCT01434407

Obesity Type 2 Diabetes Insulin Resistance +1 more

COMPLETED NA

Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry

NCT02702713

Metabolic Syndrome

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiometabolic Risk Abdominal Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bioactive components fortified food products

Group Type EXPERIMENTAL

bioactive components fortified food products intake (biscuits and cookies)

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

control food products intake (biscuits and cookies)

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes