Nutritional Metabolomics: the Search for Dietary Exposure Variables 2

Healthy Clinical Trial

Official title:

Nutritional Metabolomics: the Search for Dietary Exposure Variables 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039609
• Other study ID #: Nutritional Metabolomics AIKN2
• Status: Completed
• Start date: February 2013
• Est. completion date: January 2016

Study information

• Verified date: August 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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: 120
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Healthy Body mass index 18.0-30.0, age 18-65 yrs

Exclusion Criteria:

Regular Medication or tobacco use Pregnancy or lactating

Related Conditions & MeSH terms

• Healthy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic patterns that reflect habitual diet	Long-time vegans, vegetarians and omnivores will be asked to donate a fasting blood sample at one occasion, in the early morning. This blood sample will be analyzed, using nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques to reveal all metabolites. Patterns among these metabolites will be distinguished using the statistical techniques principal component analysis and discriminant analysis.	Fasting blood sample in the morning at one occasion
Secondary	Discriminating vegan-, vegetarian- and omnivorous diets by hair isotopic analysis	The same study group also was asked to donate 5-10 hairs of 2 cm closest to the scalp. These were analyzed using isotope ratios of 15N and 13C by IRMS, to see if also this method could discriminate between the groups	Hair samples in the morning at one occasion