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

• ClinicalTrials.gov Identifier: NCT04698889
• Recruitment Status: Completed
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Sponsor: University of Padova
• Information provided by (Responsible Party): Tessari Paolo, University of Padova

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Insulin Tolerance; Hormone; Aminoacidaemia	Dietary Supplement: natural cow; Dietary Supplement: high protein cow milk; Dietary Supplement: natural human; Dietary Supplement: low protein cow milk	Not Applicable

Detailed Description:

Objective: To determine plasma glucose, insulin, C-peptide, glucagon-like polypeptide-1 (GLP-1), glucose-inhibitory-polypeptide (GIP) and amino-acid responses, following administration of human and cow milk, either natural or with experimentally-modified casein and whey-protein content(s).

Design. Young healthy volunteers of both sexes will receive iso-lactose loads (0.36 g lactose / kg body weight) of: natural cow milk; natural human milk; and of cow milk with modified casein and whey protein contents. Blood samples will be frequently collected over 4 hours. Plasma glucose, amino acids, insulin and incretin concentrations will be measured.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Study of the Effects of Ingestion of Natural Human, Natural Cow, and Modified-cow Milk, on Glucose, Amino Acids, Insulin, and Incretin Responses in Humans
• Actual Study Start Date: April 7, 2015
• Actual Primary Completion Date: February 5, 2019
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cow milk; Administration of natural cow whole milk	Dietary Supplement: natural cow
Active Comparator: Human milk; Administration of natural human milk	Dietary Supplement: natural human
Active Comparator: Modified cow milk - low protein; Administration of modified cow milk at low protein content	Dietary Supplement: low protein cow milk
Active Comparator: Modified cow milk - high protein; Administration of modified cow milk at high protein content	Dietary Supplement: high protein cow milk

Outcome Measures

Primary Outcome Measures :

1. Plasma insulin and c-peptide [ Time Frame: 1 year ]
   microunits and nanomoles
2. Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1 [ Time Frame: 1 year ]
   picomol/L and picogram/mL

Secondary Outcome Measures :

1. Plasma Amino acids [ Time Frame: 2 years ]
   micromol/L

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Age 20-35 yrs
• Both sexes
• Healthy
• In post-absorptive state
• Hemoglobin Hb1c values within normal values.
• Previous regular, moderate physical activity
• Stable body weight and regular dietary habits.

Exclusion Criteria:

• Familial or personal history of diabetes.
• Altered fasting glucose and/ or impaired glucose tolerance.
• Any metabolic, hormonal, hepatic, renal, and cardiovascular disease.
• Current drug treatments

Contacts and Locations

No Contacts or Locations Provided

  Study Documents (Full-Text)

Documents provided by Tessari Paolo, University of Padova:

Statistical Analysis Plan  [PDF] February 12, 2015

Study Protocol  [PDF] February 12, 2015

Informed Consent Form  [PDF] February 12, 2015

More Information

• Responsible Party: Tessari Paolo, Professor, MD, University of Padova
• ClinicalTrials.gov Identifier: NCT04698889
• Other Study ID Numbers: Tessari Protocol 1
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tessari Paolo, University of Padova:

cow milk; human milk; incretins; casein; whey proteins