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CompletedNCT02039596Updated Jan 17, 2014

Nutritional Metabolomics: the Search for Dietary Exposure Variables

An interventional study of Diet in Nutrition Disorders and Metabolic Disorders, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-17.

Sponsored by Göteborg University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nutrition Disorders
  • Metabolic Disorders
03

In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 53 is below the median of 117 across 194 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medications or tobacco use
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • 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

Interventions

  • OtherDiet
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What researchers measure

Primary outcomes

  1. Acute metabolomic response

    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.

    Time frame: Directly after ingestion of test meal

07

Study locations

1 site
  • Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg
    Gothenburg, S-40530, Sweden
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References and documents

Publications

  • Radjursoga M, Lindqvist HM, Pedersen A, Karlsson GB, Malmodin D, Brunius C, Ellegard L, Winkvist A. The 1H 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. PubMed 30961592 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02039596
Lead sponsor
Göteborg University
Responsible party
Sponsor
First posted
Jan 17, 2014
Start date
Sep 2012
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jan 17, 2014

Study contacts

Anna K Winkvist, PhD
principal investigator · Univ of Gothenburg, Sweden
Lars H Ellegard, PhD, MD
study chair · Univ of Gothenburg
Helen M Lindqvist, PhD
study director · Univ of Gothenburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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