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

Primary Purpose

Metabolic Syndrome, Insulin Resistance, Overweight

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Multifunctional diet (MFD)
Control diet
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome, Overweight

Eligibility Criteria

50 Years - 73 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Functional Food Science Centre. Lund University Medicon Village

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multifunctional diet (MFD)

Control diet

Arm 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.

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

Outcomes

Primary Outcome Measures

Change from baseline in LDL cholesterol after each dietary period
Start and End of the intervention arm

Secondary Outcome Measures

Change from baseline in body weight after each dietary period
Start and End of the intervention arm

Full Information

First Posted
May 22, 2014
Last Updated
December 2, 2015
Sponsor
Lund University
Collaborators
Vinnova
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1. Study Identification

Unique Protocol Identification Number
NCT02148653
Brief Title
An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Vinnova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Overweight
Keywords
Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifunctional diet (MFD)
Arm Type
Experimental
Arm 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.
Arm Title
Control diet
Arm Type
Experimental
Arm Description
Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.
Intervention Type
Other
Intervention Name(s)
Multifunctional diet (MFD)
Intervention Description
A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
A nutritionally well formulated diet that excludes the functional food items present in the MFD.
Primary Outcome Measure Information:
Title
Change from baseline in LDL cholesterol after each dietary period
Description
Start and End of the intervention arm
Time Frame
Time 0 and after week 8
Secondary Outcome Measure Information:
Title
Change from baseline in body weight after each dietary period
Description
Start and End of the intervention arm
Time Frame
Week 0 and after 8 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in circulating triglycerides
Description
Start and End of the intervention arm
Time Frame
Week 0 and after 8 weeks
Title
Change from base line in the diversity of gut microbiota
Description
Start and End of the intervention arm
Time Frame
Week 0 and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juscelino Tovar, PhD
Organizational Affiliation
Antidiabetic Food Centre & Functional Food Science Centre. Lund University
Official's Role
Study Chair
Facility Information:
Facility Name
Functional Food Science Centre. Lund University Medicon Village
City
Lund
ZIP/Postal Code
SE 223 81
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22472183
Citation
Tovar J, Nilsson A, Johansson M, Ekesbo R, Aberg AM, Johansson U, Bjorck I. A diet based on multiple functional concepts improves cardiometabolic risk parameters in healthy subjects. Nutr Metab (Lond). 2012 Apr 2;9:29. doi: 10.1186/1743-7075-9-29.
Results Reference
background
PubMed Identifier
23855966
Citation
Nilsson A, Tovar J, Johansson M, Radeborg K, Bjorck I. A diet based on multiple functional concepts improves cognitive performance in healthy subjects. Nutr Metab (Lond). 2013 Jul 15;10:49. doi: 10.1186/1743-7075-10-49. eCollection 2013.
Results Reference
background
PubMed Identifier
26370118
Citation
Tovar J, Johansson M, Bjorck I. A multifunctional diet improves cardiometabolic-related biomarkers independently of weight changes: an 8-week randomized controlled intervention in healthy overweight and obese subjects. Eur J Nutr. 2016 Oct;55(7):2295-306. doi: 10.1007/s00394-015-1039-2. Epub 2015 Sep 14.
Results Reference
result
PubMed Identifier
29098426
Citation
Marungruang N, Tovar J, Bjorck I, Hallenius FF. Improvement in cardiometabolic risk markers following a multifunctional diet is associated with gut microbial taxa in healthy overweight and obese subjects. Eur J Nutr. 2018 Dec;57(8):2927-2936. doi: 10.1007/s00394-017-1563-3. Epub 2017 Nov 2.
Results Reference
derived

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

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