Nutritional Metabolomics: the Search for Dietary Exposure Variables

Nutrition Disorders Clinical Trial

Official title:

Nutritional Metabolomics: the Search for Dietary Exposure Variables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039596
• Other study ID #: Nutritional Metabolomics AIKN
• Secondary ID: 2011-20497-84904
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: January 16, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index 18.5-30.0

• Age 18-65 years old

Exclusion Criteria:

• Medications or tobacco use

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Disease
• Metabolic Diseases
• Metabolic Disorders
• Nutrition Disorders

Intervention

Other:
• Diet

Locations

Country	Name	City	State
Sweden	Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Directly after ingestion of test meal	No