The Impact of Milk Protein Glycation on Protein Digestion and Absorption

NCT05479916 | Completed DMC

• 1 other identifier: METC 22-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Protein intake is an essential stimulus for muscle protein anabolism. The muscle protein synthetic response to protein ingestion is mainly determined by the post-prandial plasma amino acid response. Milk protein often undergoes glycation during commonly applied milk processing procedures (Maillard reaction). We have previously shown that glycated protein results in lower postprandial amino acid levels. The level of protein glycation in processed dairy products might therefore be an important modulator of the overall protein quality of a product, and its ability to stimulate protein metabolism. However, it has not yet been investigated if the glycation level of dietary protein modulates its appearance in plasma as amino acids. Objective: To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men. Study design: Double blinded, randomized cross-over study. Study population: 15 healthy young males, aged 18-35 years. Intervention (if applicable): All subjects will perform two experiments in a double-blinded, randomized order: ingest 40 g of milk protein with 5% glycation level in 600 mL water, or 40 g of milk protein with 50% glycation level in 600 mL water. After ingestion, blood samples will be taken at regular intervals during a 6 hour period. Main study parameters/endpoints: The primary endpoint will be the appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology.

Conditions

Protein Digestion & Absorption

Keywords

Protein digestion; Protein glycation; Processing

Outcome Measures

Primary Outcomes (1)

• Plasma appearance of dietary amino acids

  Appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology

  0-6 hours

Secondary Outcomes (6)

• Whole-body protein kinetics

  0-6 hours

• Whole body protein metabolism

  0-6 hours

• Peak plasma lysine concentration

  0-6 hours

• Overall plasma amino acid responses

  0-6 hours

• Plasma glucose concentrations

  0-6 hours

Other Outcomes (7)

• Age

  Baseline

• Body weight

  Baseline

• Body length

  Baseline

Study Arms (2)

Low glycated milk protein

EXPERIMENTAL

40 grams of low glycated milk protein, blocked lysine level \~5%

Dietary Supplement: Low glycated milk protein

High glycated milk protein

EXPERIMENTAL

40 grams of high glycated milk protein, blocked lysine level \~50%

Dietary Supplement: High glycated milk protein

Interventions

Low glycated milk protein DIETARY_SUPPLEMENT

40 grams of protein dissolved in 600 mL of water

Low glycated milk protein

High glycated milk protein DIETARY_SUPPLEMENT

40 grams of protein dissolved in 600 mL of water

High glycated milk protein

Eligibility Criteria

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

You may qualify if:

• Males
• Aged between 18-35 years
• Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
• ≤ BMI ≤ 30 kg/m2
• No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

You may not qualify if:

• Smoking
• Lactose intolerant or allergies to milk proteins
• Musculoskeletal disorders
• Metabolic disorders
• Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
• Chronic use of gastric acid suppressing medication or anti-coagulants
• Unstable weight over the last three months
• Diagnosed GI tract disorders or diseases
• Blood donation in the past 2 months

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• FrieslandCampina: collaborator

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

• van Lieshout GA, Trommelen J, Nyakayiru J, van Kranenburg J, Senden JM, Gijsen AP, Verdijk LB, Pellikaan WF, Bragt MC, van Loon LJ. Protein glycation compromises the bioavailability of milk protein-derived lysine in vivo in healthy adult males: a double-blind, randomized cross-over trial. Am J Clin Nutr. 2025 Apr;121(4):804-815. doi: 10.1016/j.ajcnut.2025.01.025. Epub 2025 Jan 25.

  PMID: 39870248 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized, cross-over intervention study

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 29, 2022
• Study Start: March 15, 2023
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)