Identification of metabolomic biomarkers to assess dietary exposure in free-living adults

Not Applicable

Completed

• Conditions: Topic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes); Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN88921234
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33195362/ (added 18/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-03
• Study Completion: 2014-12-19
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Age 18-80
2. Male or female
3. Normal weight or overweight (body mass index 18.5-29.9 kg/m2)

Exclusion Criteria

1. Weight change of more than 3kg in the preceding 2 months
2. Current smokers
3. Substance abuse
4. Excess alcohol intake
5. Pregnancy
6. Diabetes (Type 1 and Type 2)
7. Cardiovascular disease
8. Cancer
9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
10. Kidney disease
11. Liver disease
12. Pancreatitis
13. Food allergy
14. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal imbalance, including but not exclusive to: antiinflammatory drugs (NSAIDs), steroids or other immunosuppressive medication, androgens, phenytoin, erythromycin or thyroid hormones

Subjects with the above conditions/taking the above medications would have an altered pattern of hormones and inflammatory molecules because of their disease process which may lead to misleading results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clearly distinguishable metabolomic profiles for chosen foods/food groups, measured using mass spectrometry from samples collected on Days 1 - 5 of each study week

Secondary Outcome Measures

Name	Time	Method
<br> 1. Distinguishable metabolomic profiles for chosen foods when using minimally invasive urine sampling<br> 2. Distinguishable metabolomic profiles for different food formulations<br> Both measured using mass spectrometry from samples collected on Days 1 - 5 of each study week<br>