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

NCT ID: NCT03384719

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2018-12-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

35 g protein (100% milk)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arla Foods

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Christian Mølgaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Mølgaard, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Exercise and sports, University of Copenhagen

Benedikte Grenov, postdoc

Role: STUDY_CHAIR

Department of Nutrition, Exercise and sports, University of Copenhagen

Anni Larnkjær, PhD

Role: STUDY_CHAIR

Department of Nutrition, Exercise and sports, University of Copenhagen

Camilla T. Damsgaard, Associate Professor

Role: STUDY_CHAIR

Department of Nutrition, Exercise and sports, University of Copenhagen

Locations

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, Denmark

Countries

Denmark

References

Grenov B, Larnkjaer A, Ritz C, Michaelsen KF, Damsgaard CT, Molgaard C. The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial. Growth Horm IGF Res. 2021 Oct-Dec;60-61:101418. doi: 10.1016/j.ghir.2021.101418. Epub 2021 Jul 21.

Reference Type: RESULT

PMID: 34333391 (View on PubMed)

Other Identifiers

D221

Identifier Type: -

Identifier Source: org_study_id