Back to resultsThe Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children (PROGRO)
Primary Purpose
Growth Acceleration, Growth; Stunting, Nutritional
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
35 g protein (30% milk + 70% rapeseed)
35 g protein (54% milk + 46% rapeseed)
35 g protein (100% milk)
Sponsored by
About this trial
This is an interventional basic science trial for Growth Acceleration focused on measuring Growth factor, Protein, Milk protein, Plant protein, Insulin-like growth factor-1 (IGF-1), Insulin, Insulin-like growth factor-binding protein-3 (IGFBP-3)
Eligibility Criteria
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
Sites / Locations
- Department of Nutrition, Exercise and Sports
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
35 g protein (30% milk + 70% rapeseed)
35 g protein (54% milk + 46% rapeseed)
35 g protein (100% milk)
Arm Description
35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening
35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening
35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening
Outcomes
Primary Outcome Measures
Change in IGF-I between study arms
Blood sample
Secondary Outcome Measures
Change in IGF-1 within study arms
Blood sample
Change in IGF-1 between and within study arms
Blood sample
Change in IGFBP-3 between and within study arms
Blood sample
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.
Change in insulin between and within study arms
Blood sample
Change in relative insulin resistance between and within study arms
Blood sample
Change in beta cell function between and within study arms
Blood sample
Change in beta cell function/insulin resistance between and within study arms
Blood sample. Beta cell function divided by insulin resistance.
Full Information
NCT ID
NCT03384719
First Posted
December 13, 2017
Last Updated
August 16, 2021
Sponsor
University of Copenhagen
Collaborators
Arla Foods, University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT03384719
Brief Title
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
Acronym
PROGRO
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Arla Foods, University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
35 g protein (30% milk + 70% rapeseed)
Arm Type
Experimental
Arm Description
35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening
Arm Title
35 g protein (54% milk + 46% rapeseed)
Arm Type
Experimental
Arm Description
35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening
Arm Title
35 g protein (100% milk)
Arm Type
Active Comparator
Arm Description
35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening
Intervention Type
Dietary Supplement
Intervention Name(s)
35 g protein (30% milk + 70% rapeseed)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
35 g protein (54% milk + 46% rapeseed)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
35 g protein (100% milk)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in IGF-I between study arms
Description
Blood sample
Time Frame
from baseline to week 4
Secondary Outcome Measure Information:
Title
Change in IGF-1 within study arms
Description
Blood sample
Time Frame
from baseline to week 4
Title
Change in IGF-1 between and within study arms
Description
Blood sample
Time Frame
from baseline to week 1
Title
Change in IGFBP-3 between and within study arms
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in the ratio IGF-1/IGFBP-3 between and within study arms
Description
Blood sample. Concentration of IGF-1 divided by the concentration of IGFBP-3.
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in insulin between and within study arms
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in relative insulin resistance between and within study arms
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in beta cell function between and within study arms
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in beta cell function/insulin resistance between and within study arms
Description
Blood sample. Beta cell function divided by insulin resistance.
Time Frame
from baseline to week 1 and week 4, respectively
Other Pre-specified Outcome Measures:
Title
Change in weight
Description
The weight is measured once on a digital weighing scale (Tanita MC 780) in kg
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in body mass index (BMI)
Description
BMI = weight divided by height squared (kg/m2). Weight is measured once using a digital weighing scale while the child is wearing underwear (Tanita MC 780, unit: kg) and height is measured three times to the nearest millimeter using a stadiometer (unit: meter).
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in waist circumference
Description
Measured three times to the nearest millimeter using a non-elastic measuring tape
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in bio impedance
Description
Tanita MC 780MA segmental multi frequency body composition analyzer
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in subscapular and triceps skinfolds
Description
Subscapular and triceps skinfolds are measured three times to the non-dominant side to the nearest 0.2 millimeter using a Harpenden skinfold caliper while the child is standing
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in free amino acids in plasma
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in height
Description
Height is measured three times to the nearest millimeter using a stadiometer
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in blood pressure
Description
Blood pressure will be measured three times by an automated medical device while the child is lying down. Blood pressure is measured after 10 minutes rest
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in pulse rate
Description
Blood pressure and pulse will be measured three times by an automated medical device while the child is lying down. Blood pressure and pulse are measured after 10 minutes rest
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in appetite hormones
Description
Blood sample: leptin
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in appetite hormones
Description
Blood sample: adiponectin
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks)
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in bone specific alkaline phosphatase
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in osteocalcin
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in genetics
Description
Blood sample: epigenetics and genes related to the study outcomes (single nucleotides polymorphisms (SNPs) and genome wide association studies (GWAS), NOT full genome sequencing
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in metabolomics related to the study outcomes
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
Title
Change in proteomics related to the study outcomes
Description
Blood sample
Time Frame
from baseline to week 1 and week 4, respectively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Mølgaard, professor
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benedikte Grenov, postdoc
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anni Larnkjær, PhD
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Camilla T. Damsgaard, Associate Professor
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34333391
Citation
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.
Results Reference
result
Learn more about this trial
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
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