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Biomarker study; study to identify biomarkers for protein intake, a randomized, fully controlled feeding study

Biomarker study; study to identify biomarkers for protein intake, a randomized, fully controlled feeding study - Biomarker Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36525
Enrollment
25
Registered
2011-03-08
Start date
2011-03-21
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geen aandoeningen

Interventions

Participants will receive a diet with usual macronutrient composition during one week (approximately 15 en% protein, 55 en% carbohydrates and 30 en% Fat). After this run in period participants will

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-40 years BMI between 18.5 and 30 kg/m2 Healthy (As judged by the participant) For women: using oral contraceptives Written informed consent obtained

Exclusion criteria

Exclusion criteria: Unusual dietary patterns, including high alcohol intakes (>= 2 glasses/day) and a vegetarian diet Usage of an energy restricted diet during the last two months Weight loss or weight gain of 5 kg or more during the last two months Smoking Any chronic disease Usage of any prescribed medication except for oral contraceptives For women: pregnant or lactating For women: Unwilling to use oral contraceptives for consecutively for at least the total study duration Liver function parameters (ALAT, ASAT, and γ-GT) and renal function parameters (Serum creatinin) outside the normal range

Design outcomes

Primary

MeasureTime frame
Blood and 24h urines that are collected during the last day of each period will be explored for potential biomarkers of meat protein, dairy protein or grain and legume protein. Urine and blood will at least be analysed for potential biomarkers postulated in other studies, amino acids, and possibly other potential biomarkers that may be identified in future studies. Furthermore, we aim to identify new biomarkers through metabolomics using Nuclear magnetic resonance spectroscopy (NMR spectroscopy) and proteomics using mass spectometry.

Secondary

MeasureTime frame
- Net acid excretion will be measured in urine and computed from the diets. - Serum creatinine, 24h urinary creatinine and urinary albumin will be measured to estimate intrarenal pressure (=measure of hyperfiltration) - Excretion of sodium will be measured to estimate sodium retention. - In blood, volume distribution of ingested bromide will be measured to estimate extracellular volume

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)