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

Not Applicable

Completed

• Conditions: Insulin Resistance; Overweight; Metabolic Syndrome
• Interventions: Other: Control diet; Other: Multifunctional diet (MFD)

• Registration Number: NCT02148653
• Lead Sponsor: Lund University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Primary Completion: 2015-01
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Normal fasting blood glucose (max 6.1 mmol /l)
• BMI between 25 and 32 Kg/m2

Exclusion Criteria

• treatment for hypercholesterolemia
• treatment for hypertension
• history of cardiovascular complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control diet	Control diet	Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.
Multifunctional diet (MFD)	Multifunctional diet (MFD)	Subjects eat a diet designed according to the Nordic Nutrition Recommendations with the addition of important amounts of various functional food concepts: Low GI and GI-modulating food items; Natural antioxidant-rich items, Long chain omega-3 fatty acid-rich fish; Betaglucan-rich barley and oat food/drinks; Cholesterol-modulating foods.

Primary Outcome Measures

Name	Time	Method
Change from baseline in LDL cholesterol after each dietary period	Time 0 and after week 8	Start and End of the intervention arm

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weight after each dietary period	Week 0 and after 8 weeks	Start and End of the intervention arm

Trial Locations

Locations (1)

Functional Food Science Centre. Lund University Medicon Village; 🇸🇪 Lund, Sweden