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

Lund University

Status: Completed

Conditions: Overweight; Insulin Resistance; Metabolic Syndrome

Treatments: Other: Multifunctional diet (MFD); Other: Control diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02148653

AFC-JT-MFD

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 50 to 73 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Multifunctional diet (MFD)

Experimental group

Description:

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.

Treatment:

Other: Multifunctional diet (MFD)

Control diet

Experimental group

Description:

Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.

Treatment:

Other: Control diet