Stable Isotope Method to Assess Dietary Protein Quality

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Rationale: 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 minimal invasive method to evaluate protein quality in humans.

Objective: The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a minimal invasive method that can be used to assess protein quality in human subjects. For this purpose, our primary objectives are to define the digestive and metabolic behaviour and distribution of the 15N-intrinsically-labelled milk protein compared to the internal standard 13C-spirulina.

Study design: Randomized cross-over trial with two experimental meals. Study population: Healthy male and female, age 18-35y Intervention (if applicable): On two separate test days, subjects will receive a semi liquid meal (pudding) divided in 9 portions, (meal 1: 27 En% Protein,10 En% fat, 62 En% carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En% carbohydrates), with intrinsically labelled 15N protein powder. Furthermore, the meal will contain a trace amount of 13C-labelled algae protein as an internal standard. Meals will differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.

Main study parameters/endpoints: The ratio of isotopic enrichment (15N/13C) of (total) amino acids of the test meal and the blood plasma as determined by (gas chromatography-) isotope ratio mass spectrometry ((GC)-IRMS).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A meal challenge with intrinsically labelled protein and addition of stable isotope tracer is frequently used in postprandial studies. Stable isotopes are naturally occurring isotopes and are not harmful for subjects, as there is no decay. Furthermore, placing venous catheters and blood sampling can occasionally cause a local haematoma or bruise and some participants may report pain or discomfort. Subjects have to come to the research facility three times, a screening visit of 1 hour, and 2 experimental days of 7 hours. Subjects will be financially compensated for participation. ;

Study Design

Related Conditions & MeSH terms

Biological Availability

Clinical Trial Details

NCT number	NCT02966704
Study type	Interventional
Source	Wageningen University
Contact
Status	Completed
Phase	N/A
Start date	July 21, 2016
Completion date	November 21, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05544786` - Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.	Phase 1
Completed	`NCT04744233` - Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.	N/A
Completed	`NCT05561075` - Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO)	N/A
Completed	`NCT03873909` - Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit	N/A
Completed	`NCT03353857` - Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam	Phase 1
Completed	`NCT05121506` - A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults	Phase 1
Completed	`NCT01267201` - A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form	Phase 1
Completed	`NCT02538393` - Relative Bioavailability of Sorafenib Tablet for Oral Suspension	Phase 1
Completed	`NCT05116982` - Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL)	N/A
Completed	`NCT04207372` - Protein Digestibility of Whey and Zein.	N/A
Completed	`NCT01853800` - Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet	Phase 1
Completed	`NCT00714584` - Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers	Phase 1
Completed	`NCT04876261` - Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements	N/A
Completed	`NCT03886597` - Nutritional Intervention With Table Olives in Healthy Volunteers	Phase 1/Phase 2
Completed	`NCT06289140` - Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2)	N/A
Completed	`NCT05439408` - Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions	Phase 1
Completed	`NCT03951025` - Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)	Phase 2
Completed	`NCT03984916` - Study of the Bioavailability of Three Hesperidin Extracts.	N/A
Completed	`NCT02847117` - Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults.	N/A
Completed	`NCT03048110` - Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction	Phase 1