NCT04698889: PROLAT

Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.

Completed NA Last updated 7 January 2021

What this trial tests

NA trial testing natural cow in Insulin Tolerance in 17 participants. Completed in 1 October 2020.

Timeline

7 April 2015

Primary endpoint
5 February 2019

1 October 2020

Quick facts

Lead sponsor	University of Padova
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	17
Start date	7 April 2015
Primary completion	5 February 2019
Estimated completion	1 October 2020

Drugs / interventions tested

• natural cow
• high protein cow milk
• natural human
• low protein cow milk

Conditions studied

• Insulin Tolerance — all drugs for Insulin Tolerance →
• Hormone — all drugs for Hormone →
• Aminoacidaemia — all drugs for Aminoacidaemia →

Sponsor

University of Padova

Who can join

Adults 20 to 35, any sex, with Insulin Tolerance or Hormone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Human milk, despite a much lower protein content, is as effective as cow milk on insulin stimulation under iso-lactose conditions. The causes for such a similar potency are unknown. This effect could be due to incretin and amino-acid responses, and/or to milk-protein interactions.In this study the investigators will address the above question(s) by testing, in young healthy volunteers, the effects of natural cow and human milk, as well as of the manipulation of the casein and whey protein content in cow milk, on insulin, C-peptide, GLP-1 and GIP secretion, as well as on circulating amino acids.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Reversal of Whey-Protein to Casein Ratio of Cow Milk, on Insulin, Incretin, and Amino Acid Responses in Humans.
   Toffolon A, de Rocco-Ponce M, Vettore M, Iori E, et al · · 2021 · cited 10× · PMID 34618402 · DOI 10.1002/mnfr.202100069
2. Neither Incretin or Amino Acid Responses, nor Casein Content, Account for the Equal Insulin Response Following Iso-Lactose Loads of Natural Human and Cow Milk in Healthy Young Adults.
   Tessari P, Toffolon A, Vettore M, Iori E, et al · · 2022 · cited 2× · PMID 35458186 · DOI 10.3390/nu14081624