Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958, Denmark
NCT Number: NCT03384719
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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Notify Me7 year–8 year
All sexes
Interventional
Not applicable
Copenhagen, Frederiksberg, 1958, Denmark
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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):
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):
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):
Time frame: from baseline to week 4
Blood sample
Time frame: from baseline to week 4
Blood sample
Time frame: from baseline to week 1
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample. Concentration of IGF-1 divided by the concentration of IGFBP-3.
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample. Beta cell function divided by insulin resistance.
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
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).
Time frame: from baseline to week 1 and week 4, respectively
Measured three times to the nearest millimeter using a non-elastic measuring tape
Time frame: from baseline to week 1 and week 4, respectively
Tanita MC 780MA segmental multi frequency body composition analyzer
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
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Height is measured three times to the nearest millimeter using a stadiometer
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
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
Time frame: from baseline to week 1 and week 4, respectively
Blood sample: leptin
Time frame: from baseline to week 1 and week 4, respectively
Blood sample: adiponectin
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
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
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
Time frame: from baseline to week 1 and week 4, respectively
Blood sample
University of Copenhagen
Other
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
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