NCT03796897

Supplementation of a Leucine-enriched Protein Blend

Completed EARLY_PHASE1 Last updated 20 June 2024

What this trial tests

EARLY_PHASE1 trial testing Leucine-enriched protein in Dietary Modification in 8 participants. Completed in 1 March 2020.

Timeline

1 June 2019

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	McMaster University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	8
Start date	1 June 2019
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Leucine-enriched protein
• Habitual diet only

Conditions studied

• Dietary Modification — all drugs for Dietary Modification →
• Diet Habit — all drugs for Diet Habit →

Sponsor

McMaster University

Who can join

Adults 18 to 29, any sex, with Dietary Modification or Diet Habit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is well known that dietary protein transiently stimulates muscle protein synthesis (MPS) whereby changes in MPS in response to feeding may be regulated by specific downstream target proteins of mammalian target of rapamycin signaling, such as S6K1, rpS6, and eIF2B. A meal deficient in protein, however, does not increase the rate of MPS because a rise in the bioavailability of amino acids does not occur. In addition, the source of dietary proteins has been shown to impact postprandial blood levels of amino acids. The concept that certain types of proteins are "fast acting" or "slow acting" has been shown to affect the postprandial profile of amino acids appearing in the systemic circulation. Native whey and micellar casein are both dairy proteins that contain a similar amount of essential (EAA), but blood EAA levels increase faster and to a higher level after the consumption of whey protein. Differences in gastric emptying, digestion and absorption kinetics between micellar casein and native whey are the underlying factors. Nonetheless, micellar casein protein has been shown to protract MPS in humans. Despite the significant amount of information gained with respect to both of these protein sources, the effects of combinatorial formulations on the postprandial profile of amino acids appearing in the blood is less well known.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Increased protein intake derived from leucine-enriched protein enhances the integrated myofibrillar protein synthetic response to short-term resistance training in untrained men and women: a 4-day randomized controlled trial.
   Lim C, Traylor DA, McGlory C, Joanisse S, et al · · 2022 · cited 4× · PMID 36126327 · DOI 10.1139/apnm-2022-0164