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

University of Copenhagen

Status: Completed

Conditions: Growth; Stunting, Nutritional; Growth Acceleration

Treatments: Dietary Supplement: 35 g protein (100% milk); Dietary Supplement: 35 g protein (30% milk + 70% rapeseed); Dietary Supplement: 35 g protein (54% milk + 46% rapeseed)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03384719

D221

Details and patient eligibility

About

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

Full 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).

Enrollment: 129 patients

Sex: All

Ages: 7 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups

35 g protein (30% milk + 70% rapeseed)

Experimental group

Description:

35 g protein per day (30% milk + 70% rapeseed) provided as a powder to be consumed every morning and evening

Treatment:

Dietary Supplement: 35 g protein (30% milk + 70% rapeseed)

35 g protein (54% milk + 46% rapeseed)

Experimental group

Description:

35 g protein per day (54% milk + 46% rapeseed) provided as a powder to be consumed every morning and evening

Treatment:

Dietary Supplement: 35 g protein (54% milk + 46% rapeseed)

35 g protein (100% milk)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 35 g protein (100% milk)