Nutritional Metabolomics: the Search for Dietary Exposure Variables

January 16, 2014 updated by: Göteborg University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, S-40530
        • Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Medications or tobacco use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Directly after ingestion of test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nutritional Metabolomics AIKN
  • 2011-20497-84904-38 (Other Grant/Funding Number: The Swedish Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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