An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02148653|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : December 3, 2015
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.
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Insulin Resistance Overweight||Other: Multifunctional diet (MFD) Other: Control diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||November 2015|
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.
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.
Experimental: Control diet
Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD.
Other: Control diet
A nutritionally well formulated diet that excludes the functional food items present in the MFD.
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148653
|Functional Food Science Centre. Lund University Medicon Village|
|Lund, Sweden, SE 223 81|
|Study Chair:||Juscelino Tovar, PhD||Antidiabetic Food Centre & Functional Food Science Centre. Lund University|