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Nutritional Metabolomics: the Search for Dietary Exposure Variables

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. Identifier: NCT02039596
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.

Condition or disease Intervention/treatment Phase
Nutrition Disorders Metabolic Disorders Other: Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Nutritional Metabolomics: the Search for Dietary Exposure Variables
Study Start Date : September 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: vegetarian breakfast
Diet: Vegetarian food items
Other: Diet
Experimental: Swedish Breakfast
Diet: Swedish food items
Other: Diet
Experimental: English breakfast
Diet: English food items
Other: Diet
Experimental: Lacto-vegetarian breakfast
Diet: Lacto-vegetarian food items
Other: Diet
Experimental: Swedish omnivore breakfast
Diet: Swedish breakfast with meat items
Other: Diet

Primary Outcome Measures :
  1. Acute metabolomic response [ Time Frame: Directly after ingestion of test meal ]
    The acute metabolomic response (ie all metabolites) to a test meal will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body mass index 18.5-30.0
  • Age 18-65 years old

Exclusion Criteria:

  • Medications or tobacco use

Information from the National Library of Medicine

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 identifier (NCT number): NCT02039596

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Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg
Gothenburg, Sweden, S-40530
Sponsors and Collaborators
Göteborg University
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Principal Investigator: Anna K Winkvist, PhD Univ of Gothenburg, Sweden
Study Chair: Lars H Ellegard, PhD, MD Univ of Gothenburg
Study Director: Helen M Lindqvist, PhD Univ of Gothenburg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Göteborg University Identifier: NCT02039596    
Other Study ID Numbers: Nutritional Metabolomics AIKN
2011-20497-84904-38 ( Other Grant/Funding Number: The Swedish Research Council )
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Nutrition Disorders
Metabolic Diseases
Pathologic Processes