Clinical trial NCT03384719: The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
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
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: University of Aarhus
First posted: 2017-12-27
Enrollment: 129
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Change in IGF-I between study arms
timeFrame: from baseline to week 4
Secondary outcomes:
measure: Change in IGF-1 within study arms
timeFrame: from baseline to week 4
measure: Change in IGF-1 between and within study arms
timeFrame: from baseline to week 1
measure: Change in IGFBP-3 between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in the ratio IGF-1/IGFBP-3 between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in insulin between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in relative insulin resistance between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in beta cell function between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in beta cell function/insulin resistance between and within study arms
timeFrame: from baseline to week 1 and week 4, respectively
Other outcomes:
measure: Change in weight
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in body mass index (BMI)
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in waist circumference
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in bio impedance
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in subscapular and triceps skinfolds
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in free amino acids in plasma
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in height
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in blood pressure
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in pulse rate
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in appetite hormones
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in appetite hormones
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks)
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in bone specific alkaline phosphatase
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in osteocalcin
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in genetics
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in metabolomics related to the study outcomes
timeFrame: from baseline to week 1 and week 4, respectively
measure: Change in proteomics related to the study outcomes
timeFrame: from baseline to week 1 and week 4, respectively
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Christian Mølgaard, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Benedikte Grenov, postdoc
role: STUDY_CHAIR
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Anni Larnkjær, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Camilla T. Damsgaard, Associate Professor
role: STUDY_CHAIR
References:
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.