Growth AccelerationPROGRONCT03384719
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
A study testing 35 g protein (30% milk + 70% rapeseed), 35 g protein (54% milk + 46% rapeseed) and 35 g protein (100% milk) in people with Growth Acceleration and Growth; Stunting, Nutritional, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Acceleration, Growth; Stunting, Nutritional
- What is being tested?
- 35 g protein (30% milk + 70% rapeseed), 35 g protein (54% milk + 46% rapeseed) and 35 g protein (100% milk)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jan 2018to 18 Dec 2018
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-8 years
- Healthy*
- The child is willing to consume protein powder twice a day for 4 weeks
- The child is not a picky eater and so does not mind trying new foods and flavours
- The child speaks Danish in order to understand the study procedures
- The parents read and speak Danish in order to be properly informed about the study procedures
- Written informed consent has been obtained
- The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved
Who cannot join
- The child drinks more than 350 ml of milk per day
- Known or suspected allergy, sensitization or intolerance to milk (protein or lactose), rapeseed or mustard
- Any acute illness*
- Chronic illness or disease that may affect protein metabolism or growth*
- Chronic intake of medicine that may affect protein metabolism or growth*
- Concomitant participation in other studies involving dietary supplements or blood sampling
- Living in a household with another participating child
- The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
Official title: The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children
Read the detailed description
The main objective is to assess how different protein blends affect growth factors in children. There is evidence to support that milk protein increases growth in children in both high and low-income countries. Therefore milk protein is often used in food aid for undernourished children in low-income countries. The study investigates if plant protein can partially replace milk protein without affecting growth promotion negatively. Plant protein could potentially reduce food aid costs and at the same time be a more sustainable protein source.
The PROGRO study is a 3-arm randomized, controlled trial. The effect of consuming 35 g pure milk protein/day is compared to intake of 35 g milk and rapeseed protein/day (ratio 30:70 and 54:46, respectively) in 7-8 year old healthy Danish children. The intervention period is 4 weeks and measurements and blood sampling are performed at baseline, week 1 and week 4. A 3-day weighed dietary intake is recorded before each visit. The primary outcome is Insulin-like growth factor-1 (IGF-1).
- Conditions
- Growth Acceleration, Growth; Stunting, Nutritional
- Being tested
- 35 g protein (30% milk + 70% rapeseed), 35 g protein (54% milk + 46% rapeseed), 35 g protein (100% milk)
- Keywords
- Growth factor, Protein, Milk protein, Plant protein, Insulin-like growth factor-1 (IGF-1), Insulin, Insulin-like growth factor-binding protein-3 (IGFBP-3)
- Medical subject headings
- Growth Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 g protein (30% milk + 70% rapeseed)Dietary supplement
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
Protein powder ingredients (all are food quality):
- Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
- Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada)
- Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.
35 g protein (54% milk + 46% rapeseed)Dietary supplement
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
Protein powder ingredients (all are food quality):
- Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
- Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada)
- Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.
35 g protein (100% milk)Dietary supplement
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
Protein powder ingredients (all are food quality):
- Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
- Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.
| Study group | Role | What they receive |
|---|---|---|
| 35 g protein (30% milk + 70% rapeseed) | Experimental | 35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening Receives: Dietary Supplement: 35 g protein (30% milk + 70% rapeseed) |
| 35 g protein (54% milk + 46% rapeseed) | Experimental | 35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening Receives: Dietary Supplement: 35 g protein (54% milk + 46% rapeseed) |
| 35 g protein (100% milk) | Active comparator | 35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening Receives: Dietary Supplement: 35 g protein (100% milk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IGF-I between study arms
Blood sample
Measured: from baseline to week 4
Secondary outcomes (8)
Change in IGF-1 within study arms
Blood sample
Measured: from baseline to week 4
Change in IGF-1 between and within study arms
Blood sample
Measured: from baseline to week 1
Change in IGFBP-3 between and within study arms
Blood sample
Measured: from baseline to week 1 and week 4, respectively
Change in the ratio IGF-1/IGFBP-3 between and within study arms
Blood sample. Concentration of IGF-1 divided by the concentration of IGFBP-3.
Measured: from baseline to week 1 and week 4, respectively
Change in insulin between and within study arms
Blood sample
Measured: from baseline to week 1 and week 4, respectively
Change in relative insulin resistance between and within study arms
Blood sample
Measured: from baseline to week 1 and week 4, respectively
Change in beta cell function between and within study arms
Blood sample
Measured: from baseline to week 1 and week 4, respectively
Change in beta cell function/insulin resistance between and within study arms
Blood sample. Beta cell function divided by insulin resistance.
Measured: from baseline to week 1 and week 4, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start18 Jan 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth AccelerationStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, University of Aarhus
- Responsible party
- Principal investigator, Christian Mølgaard, University of Copenhagen
- Investigators
- Christian Mølgaard, professor, Principal investigator, University of CopenhagenBenedikte Grenov, postdoc, Study chair, University of CopenhagenAnni Larnkjær, PhD, Study chair, University of CopenhagenCamilla T. Damsgaard, Associate Professor, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384719
- Sponsor's protocol ID
- D221
- Acronym
- PROGRO
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grenov B, Larnkjaer A, Ritz C, Michaelsen KF, Damsgaard CT, Molgaard C. The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial. Growth Horm IGF Res. 2021 Oct-Dec;60-61:101418. doi: 10.1016/j.ghir.2021.101418. Epub 2021 Jul 21.
PubMed 34333391
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
- ClinicalTrials.gov ID
- NCT03384719
- Acronym / sponsor ID
- PROGRO / D221
- Conditions
- Growth Acceleration, Growth; Stunting, Nutritional
- Keywords
- Growth factor, Protein, Milk protein, Plant protein, Insulin-like growth factor-1 (IGF-1), Insulin, Insulin-like growth factor-binding protein-3 (IGFBP-3)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods, University of Aarhus
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 27 Dec 2017 (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.
The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children
Detailed description
The main objective is to assess how different protein blends affect growth factors in children. There is evidence to support that milk protein increases growth in children in both high and low-income countries. Therefore milk protein is often used in food aid for undernourished children in low-income countries. The study investigates if plant protein can partially replace milk protein without affecting growth promotion negatively. Plant protein could potentially reduce food aid costs and at the same time be a more sustainable protein source.
The PROGRO study is a 3-arm randomized, controlled trial. The effect of consuming 35 g pure milk protein/day is compared to intake of 35 g milk and rapeseed protein/day (ratio 30:70 and 54:46, respectively) in 7-8 year old healthy Danish children. The intervention period is 4 weeks and measurements and blood sampling are performed at baseline, week 1 and week 4. A 3-day weighed dietary intake is recorded before each visit. The primary outcome is Insulin-like growth factor-1 (IGF-1).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
| Arm | Type | Receives |
|---|---|---|
| 35 g protein (30% milk + 70% rapeseed) | Experimental | Dietary Supplement: 35 g protein (30% milk + 70% rapeseed)35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening |
| 35 g protein (54% milk + 46% rapeseed) | Experimental | Dietary Supplement: 35 g protein (54% milk + 46% rapeseed)35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening |
| 35 g protein (100% milk) | Active comparator | Dietary Supplement: 35 g protein (100% milk)35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 7-8 years
- Healthy*
- The child is willing to consume protein powder twice a day for 4 weeks
- The child is not a picky eater and so does not mind trying new foods and flavours
- The child speaks Danish in order to understand the study procedures
Key exclusion criteria (8 listed)
- The child drinks more than 350 ml of milk per day
- Known or suspected allergy, sensitization or intolerance to milk (protein or lactose), rapeseed or mustard
- Any acute illness*
- Chronic illness or disease that may affect protein metabolism or growth*
- Chronic intake of medicine that may affect protein metabolism or growth*
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 |
|---|---|---|
| 35 g protein (30% milk + 70% rapeseed)The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): * Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) * Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada) * Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day. | Dietary supplement | 35 g protein (30% milk + 70% rapeseed) |
| 35 g protein (54% milk + 46% rapeseed)The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): * Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) * Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada) * Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day. | Dietary supplement | 35 g protein (54% milk + 46% rapeseed) |
| 35 g protein (100% milk)The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): * Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) * Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day. | Dietary supplement | 35 g protein (100% milk) |
Primary outcome
Change in IGF-I between study arms
Time frame: from baseline to week 4
Blood sample
8 secondary outcomes
Change in IGF-1 within study arms
Time frame: from baseline to week 4
Change in IGF-1 between and within study arms
Time frame: from baseline to week 1
Change in IGFBP-3 between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
Change in the ratio IGF-1/IGFBP-3 between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
Change in insulin between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
Change in relative insulin resistance between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
Change in beta cell function between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
Change in beta cell function/insulin resistance between and within study arms
Time frame: from baseline to week 1 and week 4, respectively
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 23 Aug 2021.
- Results publication: PubMed 34333391Grenov B, Larnkjaer A, Ritz C, Michaelsen KF, Damsgaard CT, Molgaard C. The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial. Growth Horm IGF Res. 2021 Oct-Dec;60-61:101418. doi: 10.1016/j.ghir.2021.101418. Epub 2021 Jul 21.
- Individual participant dataSharing planned: Undecided
Related trials for Growth Acceleration
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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.
Christian Mølgaard, professor principal investigator
University of Copenhagen
Benedikte Grenov, postdoc study chair
University of Copenhagen
Anni Larnkjær, PhD study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35 g protein (30% milk + 70% rapeseed), 35 g protein (54% milk + 46% rapeseed) and 35 g protein (100% milk) in people with Growth Acceleration and Growth; Stunting, Nutritional, run by University of Copenhagen at 1 site in Denmark.
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 8 inclusion and 8 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in IGF-I between study arms (time frame: from baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384719, which also lists 1 linked publication.
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 23 Aug 2021.