Stable Isotope Method to Assess Dietary Protein Quality

NCT02966704 | Completed

• 1 other identifier: NL56440.081.16
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Biological Availability

Outcome Measures

Primary Outcomes (1)

• ratio of isotopic enrichment

  6 hours

Study Arms (2)

meal 1

EXPERIMENTAL

mixed meal with high level of intrinsically labeled milk protein

Dietary Supplement: intrinsically labeled milk protein

meal 2

EXPERIMENTAL

mixed meal with low level of intrinsically labeled milk protein

Dietary Supplement: intrinsically labeled milk protein

Interventions

intrinsically labeled milk protein DIETARY_SUPPLEMENT

meal 1; meal 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Age: 20 - 35 y
• BMI: 18.5 - 25 kg/m2
• Stable dietary habits
• Veins suitable for cannulation (blood sampling)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Related Publications (1)

• van der Wielen N, Khodorova NV, Gerrits WJJ, Gaudichon C, Calvez J, Tome D, Mensink M. Blood 15N:13C Enrichment Ratios Are Proportional to the Ingested Quantity of Protein with the Dual-Tracer Approach for Determining Amino Acid Bioavailability in Humans. J Nutr. 2020 Sep 1;150(9):2346-2352. doi: 10.1093/jn/nxaa205.

  PMID: 32710787 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: November 17, 2016
• Study Start: July 21, 2016
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: December 14, 2017

Record last verified: 2017-12