Biological Availability Clinical Trial
Official title:
A Dual Stable Isotope Method to Assess Dietary Protein Quality in Humans: Characterization of Intrinsically Labelled 15N Milk Protein as a Reference Protein
Verified date | December 2017 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The evaluation of protein quality has been identified as the top priority question by the
Food and Agricultural Organization (FAO) of the United Nations. However, the current
available methods do not precisely estimate protein quality, or need invasive procedures. The
proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in
humans.
The present project characterizes the use of 15N-intrinsically-labelled milk protein as a
reference-protein for development a non-invasive method that can be used to assess protein
quality in human subjects
Status | Completed |
Enrollment | 10 |
Est. completion date | November 21, 2016 |
Est. primary completion date | November 21, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Healthy - Age: 20 - 35 y - BMI: 18.5 - 25 kg/m2 - Stable dietary habits - Veins suitable for cannulation (blood sampling) Exclusion Criteria: - Having a history of medical or surgical events that may significantly affect the study outcome - Medical drug use accept incidental use of paracetamol - (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer - Milk protein intolerance - Alcohol consumption of >14 (women) or > 21 (men) units per week - Drug abuse - Moderate intense physical activity (exercise) for more than 5 hours/week - Reported weight loss or weight gain of > 3 kg in the month prior to pre-study screening - Reported slimming diet, or medically prescribed diet - Having a habitual diet with a protein content of <10 En% > 30 En% - Reported vegan or macrobiotic life-style - Recent blood donation (<1 month prior to Day 01 of the study) - Not willing to comply to the controlled dietary intervention guidelines - Not willing or afraid to give up blood donation during the study - Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives - Current and within 1 month participation in other research from the Division of Human Nutrition - Not having a general practitioner |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ratio of isotopic enrichment | 6 hours |
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