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

NCT03384719 | Completed

• 1 other identifier: D221
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Growth Acceleration; Growth; Stunting, Nutritional

Keywords

Growth factor; Protein; Milk protein; Plant protein; Insulin-like growth factor-1 (IGF-1); Insulin; Insulin-like growth factor-binding protein-3 (IGFBP-3)

Outcome Measures

Primary Outcomes (1)

• Change in IGF-I between study arms

  Blood sample

  from baseline to week 4

Secondary Outcomes (8)

• Change in IGF-1 within study arms

  from baseline to week 4

• Change in IGF-1 between and within study arms

  from baseline to week 1

• Change in IGFBP-3 between and within study arms

  from baseline to week 1 and week 4, respectively

• Change in the ratio IGF-1/IGFBP-3 between and within study arms

  from baseline to week 1 and week 4, respectively

• Change in insulin between and within study arms

  from baseline to week 1 and week 4, respectively

Other Outcomes (17)

• Change in weight

  from baseline to week 1 and week 4, respectively

• Change in body mass index (BMI)

  from baseline to week 1 and week 4, respectively

• Change in waist circumference

  from baseline to week 1 and week 4, respectively

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

35 g protein (100% milk)

ACTIVE COMPARATOR

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

Dietary Supplement: 35 g protein (100% milk)

Interventions

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 (30% milk + 70% rapeseed)

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 (54% milk + 46% rapeseed)

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.

35 g protein (100% milk)

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Arla Foods: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34333391 RESULT

MeSH Terms

Conditions

Growth Disorders; Insulin Resistance

Interventions

Proteins; Milk

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Christian Mølgaard, professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Benedikte Grenov, postdoc

  University of Copenhagen

  STUDY CHAIR

• Anni Larnkjær, PhD

  University of Copenhagen

  STUDY CHAIR

• Camilla T. Damsgaard, Associate Professor

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 27, 2017
• Study Start: January 18, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: August 23, 2021

Record last verified: 2017-12

Locations

DK (1)