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

August 16, 2021 updated by: Christian Mølgaard, University of Copenhagen

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 8 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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

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.
EXPERIMENTAL: 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

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.
ACTIVE_COMPARATOR: 35 g protein (100% milk)
35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IGF-1 within study arms
Time Frame: from baseline to week 4
Blood sample
from baseline to week 4
Change in IGF-1 between and within study arms
Time Frame: from baseline to week 1
Blood sample
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
Blood sample
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
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
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
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
Blood sample
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
Blood sample
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
Blood sample. Beta cell function divided by insulin resistance.
from baseline to week 1 and week 4, respectively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: from baseline to week 1 and week 4, respectively
The weight is measured once on a digital weighing scale (Tanita MC 780) in kg
from baseline to week 1 and week 4, respectively
Change in body mass index (BMI)
Time Frame: from baseline to week 1 and week 4, respectively
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).
from baseline to week 1 and week 4, respectively
Change in waist circumference
Time Frame: from baseline to week 1 and week 4, respectively
Measured three times to the nearest millimeter using a non-elastic measuring tape
from baseline to week 1 and week 4, respectively
Change in bio impedance
Time Frame: from baseline to week 1 and week 4, respectively
Tanita MC 780MA segmental multi frequency body composition analyzer
from baseline to week 1 and week 4, respectively
Change in subscapular and triceps skinfolds
Time Frame: from baseline to week 1 and week 4, respectively
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
from baseline to week 1 and week 4, respectively
Change in free amino acids in plasma
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively
Change in height
Time Frame: from baseline to week 1 and week 4, respectively
Height is measured three times to the nearest millimeter using a stadiometer
from baseline to week 1 and week 4, respectively
Change in blood pressure
Time Frame: from baseline to week 1 and week 4, respectively
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
from baseline to week 1 and week 4, respectively
Change in pulse rate
Time Frame: from baseline to week 1 and week 4, respectively
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
from baseline to week 1 and week 4, respectively
Change in appetite hormones
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample: leptin
from baseline to week 1 and week 4, respectively
Change in appetite hormones
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample: adiponectin
from baseline to week 1 and week 4, respectively
Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks)
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively
Change in bone specific alkaline phosphatase
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively
Change in osteocalcin
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively
Change in genetics
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample: epigenetics and genes related to the study outcomes (single nucleotides polymorphisms (SNPs) and genome wide association studies (GWAS), NOT full genome sequencing
from baseline to week 1 and week 4, respectively
Change in metabolomics related to the study outcomes
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively
Change in proteomics related to the study outcomes
Time Frame: from baseline to week 1 and week 4, respectively
Blood sample
from baseline to week 1 and week 4, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Mølgaard, professor, Department of Nutrition, Exercise and Sports, University of Copenhagen
  • Study Chair: Benedikte Grenov, postdoc, Department of Nutrition, Exercise and Sports, University of Copenhagen
  • Study Chair: Anni Larnkjær, PhD, Department of Nutrition, Exercise and Sports, University of Copenhagen
  • Study Chair: Camilla T. Damsgaard, Associate Professor, Department of Nutrition, Exercise and Sports, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 18, 2018

Primary Completion (ACTUAL)

December 18, 2018

Study Completion (ACTUAL)

December 18, 2018

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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