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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 7 Years – 8 Years
• Healthy volunteers: Accepted

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).

Conditions

• Growth Acceleration
• Growth; Stunting, Nutritional

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	35 g protein (30% milk + 70% rapeseed)	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.
DIETARY_SUPPLEMENT	35 g protein (54% milk + 46% rapeseed)	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.
DIETARY_SUPPLEMENT	35 g protein (100% milk)	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.

Timeline

• Start date: 2018-01-18
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2017-12-27
• Last updated: 2021-08-23

Locations

1 site across 1 country: Denmark