Clinical trial NCT02148653: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Overweight
Keywords: Cardiometabolic risk
Diet
Dietary prevention
Functional diet
Functional foods
Metabolic Syndrome
Overweight
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
First posted: 2014-05-28
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline in LDL cholesterol after each dietary period
timeFrame: Time 0 and after week 8
Secondary outcomes:
measure: Change from baseline in body weight after each dietary period
timeFrame: Week 0 and after 8 weeks
Other outcomes:
measure: Change from baseline in circulating triglycerides
timeFrame: Week 0 and after 8 weeks
measure: Change from base line in the diversity of gut microbiota
timeFrame: Week 0 and after 8 weeks
Locations:
city: Lund
country: Sweden
facility: Functional Food Science Centre. Lund University Medicon Village
Study officials:
affiliation: Antidiabetic Food Centre & Functional Food Science Centre. Lund University
name: Juscelino Tovar, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.