An observational study in Focus: Nutritional Deficiency, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by University of Hohenheim · Observational
This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.
Urinary collection in newborns and infants can be difficult. Our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. Participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. Participants weight, height, age, nutritional supplement use and diet will be assessed.
Participants are primarily recruited at the University of Hohenheim
Healthy volunteers Written informed consent
Exclusion Criteria:
BMI \< 18,5 and >24,9 Use of medication (except contraceptives) Smoking
Healthy volunteers without dietary restrictions
Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire
Healthy volunteers who do not consume meat products
Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire
Healthy volunteers who do not consume any animal product
Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire
urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements
Correlation untreated and expressed urine
Correlation of creatinine, methylmalonic acid and iodine between unprocessed urine and urine expressed from a sanitary diaper to evaluate possible matrix effects on analytes.
Time frame: 8-9 weeks after completion
Correlation of urinary biomarkers with food and supplement intake
Correlation of dietary intake assessed by a food frequency questionnaire with urinary iodine and methylmalonic acid normalized to creatinine.
Time frame: 8-9 weeks after completion
Mean difference of urinary biomarkers between groups
Exploratory analysis of differences by dietary group in urinary iodine nomalized to creatinin.
Time frame: 8-9 weeks after completion
Mean difference of urinary biomarkers between groups
Exploratory analysis of differences by dietary group in methylmalonic acid nomalized to creatinin.
Time frame: 8-9 weeks after completion
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Hohenheim