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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148653
• Other study ID #: AFC-JT-MFD
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: December 2, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 73 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight

Intervention

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

Locations

Country	Name	City	State
Sweden	Functional Food Science Centre. Lund University Medicon Village	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Nilsson A, Tovar J, Johansson M, Radeborg K, Björck 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. — View Citation

Tovar J, Johansson M, Björck 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. 2015 Sep 14. [Epub ahead — View Citation

Tovar J, Nilsson A, Johansson M, Ekesbo R, Aberg AM, Johansson U, Björck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in circulating triglycerides	Start and End of the intervention arm	Week 0 and after 8 weeks	No
Other	Change from base line in the diversity of gut microbiota	Start and End of the intervention arm	Week 0 and after 8 weeks	No
Primary	Change from baseline in LDL cholesterol after each dietary period	Start and End of the intervention arm	Time 0 and after week 8	No
Secondary	Change from baseline in body weight after each dietary period	Start and End of the intervention arm	Week 0 and after 8 weeks	No