Insulin TolerancePROLATNCT04698889
Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.
A study testing natural cow, high protein cow milk and natural human in people with Insulin Tolerance and Hormone, run by University of Padova.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Tolerance, Hormone, Aminoacidaemia
- What is being tested?
- natural cow, high protein cow milk and natural human
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2015to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Insulin Tolerance, Hormone, Aminoacidaemia
- Being tested
- natural cow, high protein cow milk, natural human, low protein cow milk
- Keywords
- cow milk, human milk, incretins, casein, whey proteins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural cowDietary supplement
high protein cow milkDietary supplement
natural humanDietary supplement
low protein cow milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cow milk | Active comparator | Administration of natural cow whole milk Receives: Dietary Supplement: natural cow |
| Human milk | Active comparator | Administration of natural human milk Receives: Dietary Supplement: natural human |
| Modified cow milk - low protein | Active comparator | Administration of modified cow milk at low protein content Receives: Dietary Supplement: low protein cow milk |
| Modified cow milk - high protein | Active comparator | Administration of modified cow milk at high protein content Receives: Dietary Supplement: high protein cow milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin and c-peptide
microunits and nanomoles
Measured: 1 year
Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1
picomol/L and picogram/mL
Measured: 1 year
Secondary outcomes (1)
Plasma Amino acids
micromol/L
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start7 Apr 2015
- Primary completion5 Feb 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessari Paolo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698889
- Sponsor's protocol ID
- Tessari Protocol 1
- Acronym
- PROLAT
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04698889
- Acronym / sponsor ID
- PROLAT / Tessari Protocol 1
- Conditions
- Insulin Tolerance, Hormone, Aminoacidaemia
- Keywords
- cow milk, human milk, incretins, casein, whey proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 7 Apr 2015 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
| Arm | Type | Receives |
|---|---|---|
| Cow milk | Active comparator | Dietary Supplement: natural cowAdministration of natural cow whole milk |
| Human milk | Active comparator | Dietary Supplement: natural humanAdministration of natural human milk |
| Modified cow milk - low protein | Active comparator | Dietary Supplement: low protein cow milkAdministration of modified cow milk at low protein content |
| Modified cow milk - high protein | Active comparator | Dietary Supplement: high protein cow milkAdministration of modified cow milk at high protein content |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 20-35 yrs
- Both sexes
- Healthy
- In post-absorptive state
- Hemoglobin Hb1c values within normal values.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural cow | Dietary supplement | Cow milk |
| high protein cow milk | Dietary supplement | Modified cow milk - high protein |
| natural human | Dietary supplement | Human milk |
| low protein cow milk | Dietary supplement | Modified cow milk - low protein |
Primary outcome
Plasma insulin and c-peptide
Time frame: 1 year
microunits and nanomoles
Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1
Time frame: 1 year
picomol/L and picogram/mL
1 secondary outcome
Plasma Amino acids
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing natural cow, high protein cow milk and natural human in people with Insulin Tolerance and Hormone, run by University of Padova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma insulin and c-peptide (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.