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Completed

NCT Number: NCT03384719

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

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Key information

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in IGF-I between study arms

    Time frame: from baseline to week 4

    Blood sample

Secondary outcomes

  1. Change in IGF-1 within study arms

    Time frame: from baseline to week 4

    Blood sample

  2. Change in IGF-1 between and within study arms

    Time frame: from baseline to week 1

    Blood sample

  3. Change in IGFBP-3 between and within study arms

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  4. 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.

  5. Change in insulin between and within study arms

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  6. Change in relative insulin resistance between and within study arms

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  7. Change in beta cell function between and within study arms

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  8. 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.

Other outcomes

  1. 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

  2. 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).

  3. 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

  4. Change in bio impedance

    Time frame: from baseline to week 1 and week 4, respectively

    Tanita MC 780MA segmental multi frequency body composition analyzer

  5. 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

  6. Change in free amino acids in plasma

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  7. 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

  8. 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

  9. 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

  10. Change in appetite hormones

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample: leptin

  11. Change in appetite hormones

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample: adiponectin

  12. 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

  13. Change in bone specific alkaline phosphatase

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  14. Change in osteocalcin

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  15. 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

  16. Change in metabolomics related to the study outcomes

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

  17. Change in proteomics related to the study outcomes

    Time frame: from baseline to week 1 and week 4, respectively

    Blood sample

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • University of Aarhus

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2017
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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