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Trial record 39 of 54 for:    barley

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

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ClinicalTrials.gov Identifier: NCT02148653
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
Vinnova
Information provided by (Responsible Party):
Juscelino Tovar, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Insulin Resistance Overweight Other: Multifunctional diet (MFD) Other: Control diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: 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.
Other: Multifunctional diet (MFD)
A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.

Experimental: Control diet
Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.
Other: Control diet
A nutritionally well formulated diet that excludes the functional food items present in the MFD.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   50 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148653


Locations
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Sweden
Functional Food Science Centre. Lund University Medicon Village
Lund, Sweden, SE 223 81
Sponsors and Collaborators
Lund University
Vinnova
Investigators
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Study Chair: Juscelino Tovar, PhD Antidiabetic Food Centre & Functional Food Science Centre. Lund University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juscelino Tovar, Project Manager, Lund University
ClinicalTrials.gov Identifier: NCT02148653     History of Changes
Other Study ID Numbers: AFC-JT-MFD
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Juscelino Tovar, Lund University:
Cardiometabolic risk
Diet
Dietary prevention
Functional diet
Functional foods
Metabolic Syndrome
Overweight

Additional relevant MeSH terms:
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Overweight
Metabolic Syndrome
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents