Nutritional Metabolomics: the Search for Dietary Exposure Variables

Sponsor
Göteborg University (Other)
Overall Status
Completed
CT.gov ID
NCT02039596
Collaborator
(none)
53
1
5
14
3.8

Study Details

Study Description

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
  • Other: Diet
N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2012
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Acute metabolomic response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg Gothenburg Sweden S-40530

Sponsors and Collaborators

  • Göteborg University

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT02039596
Other Study ID Numbers:
  • Nutritional Metabolomics AIKN
  • 2011-20497-84904-38
First Posted:
Jan 17, 2014
Last Update Posted:
Jan 17, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2014