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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

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE May 28, 2014
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02148653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2014)
  • Change from baseline in circulating triglycerides [ Time Frame: Week 0 and after 8 weeks ]
    Start and End of the intervention arm
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Metabolic Syndrome
  • Insulin Resistance
  • Overweight
Intervention  ICMJE
  • 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.
  • Other: Control diet
    A nutritionally well formulated diet that excludes the functional food items present in the MFD.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Multifunctional diet (MFD)
  • Experimental: Control diet
    Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.
    Intervention: Other: Control diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2014)
50
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02148653
Other Study ID Numbers  ICMJE AFC-JT-MFD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juscelino Tovar, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Vinnova
Investigators  ICMJE
Study Chair: Juscelino Tovar, PhD Antidiabetic Food Centre & Functional Food Science Centre. Lund University
PRS Account Lund University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP