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Nutritional Metabolomics: the Search for Dietary Exposure Variables

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

Tracking Information
First Submitted Date  ICMJE December 17, 2013
First Posted Date  ICMJE January 17, 2014
Last Update Posted Date January 17, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional Metabolomics: the Search for Dietary Exposure Variables
Official Title  ICMJE Nutritional Metabolomics: the Search for Dietary Exposure Variables
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Nutrition Disorders
  • Metabolic Disorders
Intervention  ICMJE Other: Diet
Study Arms  ICMJE
  • Experimental: vegetarian breakfast
    Diet: Vegetarian food items
    Intervention: Other: Diet
  • Experimental: Swedish Breakfast
    Diet: Swedish food items
    Intervention: Other: Diet
  • Experimental: English breakfast
    Diet: English food items
    Intervention: Other: Diet
  • Experimental: Lacto-vegetarian breakfast
    Diet: Lacto-vegetarian food items
    Intervention: Other: Diet
  • Experimental: Swedish omnivore breakfast
    Diet: Swedish breakfast with meat items
    Intervention: Other: Diet
Publications * Rådjursöga M, Lindqvist HM, Pedersen A, Karlsson GB, Malmodin D, Brunius C, Ellegård L, Winkvist A. The (1)H NMR serum metabolomics response to a two meal challenge: a cross-over dietary intervention study in healthy human volunteers. Nutr J. 2019 Apr 8;18(1):25. doi: 10.1186/s12937-019-0446-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2014)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Medications or tobacco use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02039596
Other Study ID Numbers  ICMJE Nutritional Metabolomics AIKN
2011-20497-84904-38 ( Other Grant/Funding Number: The Swedish Research Council )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Göteborg University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP