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Completed

NCT Number: NCT02148653

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

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Functional Food Science Centre. Lund University Medicon Village

Lund, SE 223 81, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifunctional diet (MFD)

Other

A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.

Control diet

Other

A nutritionally well formulated diet that excludes the functional food items present in the MFD.

Primary outcomes

  1. Change from baseline in LDL cholesterol after each dietary period

    Time frame: Time 0 and after week 8

    Start and End of the intervention arm

Secondary outcomes

  1. Change from baseline in body weight after each dietary period

    Time frame: Week 0 and after 8 weeks

    Start and End of the intervention arm

Other outcomes

  1. Change from baseline in circulating triglycerides

    Time frame: Week 0 and after 8 weeks

    Start and End of the intervention arm

  2. Change from base line in the diversity of gut microbiota

    Time frame: Week 0 and after 8 weeks

    Start and End of the intervention arm

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Vinnova

Registry information

Official study title

Efficacy of an Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Overweight Subjects: Studies of Mechanisms Involving Metabolomics and Gut Microbiota Mapping

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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