The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children

Study Overview
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Brief Summary
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The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children

Detailed Description
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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).

Official Title
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The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children

Conditions
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Growth Acceleration, Growth; Stunting, Nutritional

Intervention / Treatment
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* Dietary Supplement: 35 g protein (30% milk + 70% rapeseed)
* Dietary Supplement: 35 g protein (54% milk + 46% rapeseed)
* Dietary Supplement: 35 g protein (100% milk)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 35 g protein (30% milk + 70% rapeseed)<br>35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening | Dietary Supplement: 35 g protein (30% milk + 70% rapeseed)<br>* 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.<br>|
| Experimental: 35 g protein (54% milk + 46% rapeseed)<br>35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening | Dietary Supplement: 35 g protein (54% milk + 46% rapeseed)<br>* 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.<br>|
| Active Comparator: 35 g protein (100% milk)<br>35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening | Dietary Supplement: 35 g protein (100% milk)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IGF-I between study arms | Blood sample | from baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IGF-1 within study arms | Blood sample | from baseline to week 4 | 
| Change in IGF-1 between and within study arms | Blood sample | from baseline to week 1 | 
| Change in IGFBP-3 between and within study arms | Blood sample | 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. | from baseline to week 1 and week 4, respectively | 
| Change in insulin between and within study arms | Blood sample | from baseline to week 1 and week 4, respectively | 
| Change in relative insulin resistance between and within study arms | Blood sample | from baseline to week 1 and week 4, respectively | 
| Change in beta cell function between and within study arms | Blood sample | 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. | from baseline to week 1 and week 4, respectively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth factor, Protein, Milk protein, Plant protein, Insulin-like growth factor-1 (IGF-1), Insulin, Insulin-like growth factor-binding protein-3 (IGFBP-3)