An Antiinflammatory Diet as Modulator of Cardiometabolic Risk & Body

Status Completed

Clinical Trial Summary

Main scientific question:

A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD) showed remarkable reductions in cardiometabolic (CM) risk markers compared with a well-designed control diet. The study was performed under weight maintenance conditions in healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also resulted in improved cognitive performance after 4 weeks (Nilsson et al., 2013).

The present project will further study the preventive potential of MFD, using its unique properties for identification of new biomarkers and to evaluate the potential role of alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a randomized parallel design in an eight-week intervention with the test or control diet, respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are also planned. Associations between the gut microbiota composition and measures of CM risk are also included. The project provides unique opportunities to identify mechanisms for the metabolic impact of MFD, for further exploitation in innovative food and/or dietary concepts.

Central hypothesis:

The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions allowing for body weight reduction. Expected additional benefits may be recorded as reduced values for conventional CM-related parameters, markers of modified gut microbiota composition and specific changes in blood metabolite profiles.

Objectives:

- To further improve the effect of MFD on biochemical/anthropometric CM risk markers in healthy subjects by administering the diet under conditions allowing for weight reduction.

- To identify MFD-related changes in the gut microbiota associated with improved CM risk markers.

- To assess MFD-related modification in metabolic pathways, studied with a metabolomics approach, and to correlate them with conventional clinical outcomes, aiming to identify new markers of altered metabolic risk.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02148653
Study type	Interventional
Source	Lund University
Contact
Status	Completed
Phase	N/A
Start date	February 2014
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04635202` - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome	N/A
Completed	`NCT05343858` - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome	N/A
Completed	`NCT04053686` - An Intervention to Reduce Prolonged Sitting in Police Staff	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Recruiting	`NCT05040958` - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Completed	`NCT03289897` - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan	N/A
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Completed	`NCT06057896` - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting	`NCT03613740` - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion	Phase 2
Completed	`NCT04498455` - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency	Phase 4
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Completed	`NCT03241121` - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome	N/A
Completed	`NCT04509206` - Virtual Teaching Kitchen	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms