NCT02148653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

May 22, 2014

Last Update Submit

December 2, 2015

Conditions

Metabolic SyndromeInsulin ResistanceOverweight

Keywords

Cardiometabolic riskDietDietary preventionFunctional dietFunctional foodsMetabolic SyndromeOverweight

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in LDL cholesterol after each dietary period

    Start and End of the intervention arm

    Time 0 and after week 8

Secondary Outcomes (1)

  • Change from baseline in body weight after each dietary period

    Week 0 and after 8 weeks

Other Outcomes (2)

  • Change from baseline in circulating triglycerides

    Week 0 and after 8 weeks

  • Change from base line in the diversity of gut microbiota

    Week 0 and after 8 weeks

Study Arms (2)

Multifunctional diet (MFD)

EXPERIMENTAL

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)

Control diet

EXPERIMENTAL

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

Other: Control diet

Interventions

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.

Multifunctional diet (MFD)
Control dietOTHER

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

Control diet

Eligibility Criteria

Age50 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal fasting blood glucose (max 6.1 mmol /l)
  • BMI between 25 and 32 Kg/m2

You may not qualify if:

  • treatment for hypercholesterolemia
  • treatment for hypertension
  • history of cardiovascular complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Functional Food Science Centre. Lund University Medicon Village

Lund, SE 223 81, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 22472183BACKGROUND

  • 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.

    PMID: 23855966BACKGROUND

  • 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.

    PMID: 26370118RESULT

  • Arroyo CB, Ocariz MG, Rogova O, Al-Majdoub M, Bjorck I, Tovar J, Spegel P. A randomized trial involving a multifunctional diet reveals systematic lipid remodeling and improvements in cardiometabolic risk factors in middle aged to aged adults. Front Nutr. 2023 Sep 14;10:1236153. doi: 10.3389/fnut.2023.1236153. eCollection 2023.

    PMID: 37781111DERIVED

  • 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.

    PMID: 29098426DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceOverweight

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juscelino Tovar, PhD

    Antidiabetic Food Centre & Functional Food Science Centre. Lund University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 28, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2015

Study Completion

November 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

SE(1)