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Nutritional Metabolomics: the Search for Dietary Exposure Variables

Primary Purpose

Nutrition Disorders, Metabolic Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Diet
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutrition Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Medications or tobacco use

Sites / Locations

  • Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

vegetarian breakfast

Swedish Breakfast

English breakfast

Lacto-vegetarian breakfast

Swedish omnivore breakfast

Arm Description

Diet: Vegetarian food items

Diet: Swedish food items

Diet: English food items

Diet: Lacto-vegetarian food items

Diet: Swedish breakfast with meat items

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2013
Last Updated
January 16, 2014
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02039596
Brief Title
Nutritional Metabolomics: the Search for Dietary Exposure Variables
Official Title
Nutritional Metabolomics: the Search for Dietary Exposure Variables
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders, Metabolic Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vegetarian breakfast
Arm Type
Experimental
Arm Description
Diet: Vegetarian food items
Arm Title
Swedish Breakfast
Arm Type
Experimental
Arm Description
Diet: Swedish food items
Arm Title
English breakfast
Arm Type
Experimental
Arm Description
Diet: English food items
Arm Title
Lacto-vegetarian breakfast
Arm Type
Experimental
Arm Description
Diet: Lacto-vegetarian food items
Arm Title
Swedish omnivore breakfast
Arm Type
Experimental
Arm Description
Diet: Swedish breakfast with meat items
Intervention Type
Other
Intervention Name(s)
Diet
Primary Outcome Measure Information:
Title
Acute metabolomic response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index 18.5-30.0 Age 18-65 years old Exclusion Criteria: Medications or tobacco use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna K Winkvist, PhD
Organizational Affiliation
Univ of Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars H Ellegard, PhD, MD
Organizational Affiliation
Univ of Gothenburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helen M Lindqvist, PhD
Organizational Affiliation
Univ of Gothenburg
Official's Role
Study Director
Facility Information:
Facility Name
Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg
City
Gothenburg
ZIP/Postal Code
S-40530
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30961592
Citation
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.
Results Reference
derived

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Nutritional Metabolomics: the Search for Dietary Exposure Variables

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