- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384719
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children (PROGRO)
The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Frederiksberg
-
Copenhagen, Frederiksberg, Denmark, 1958
- Department of Nutrition, Exercise and Sports
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
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):
|
EXPERIMENTAL: 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
|
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):
|
ACTIVE_COMPARATOR: 35 g protein (100% milk)
35 g protein per day (100% milk) provided as a powder to be consumed every morning and evening
|
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):
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IGF-I between study arms
Time Frame: from baseline to week 4
|
Blood sample
|
from baseline to week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IGF-1 within study arms
Time Frame: from baseline to week 4
|
Blood sample
|
from baseline to week 4
|
Change in IGF-1 between and within study arms
Time Frame: from baseline to week 1
|
Blood sample
|
from baseline to week 1
|
Change in IGFBP-3 between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in the ratio IGF-1/IGFBP-3 between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample.
Concentration of IGF-1 divided by the concentration of IGFBP-3.
|
from baseline to week 1 and week 4, respectively
|
Change in insulin between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in relative insulin resistance between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in beta cell function between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in beta cell function/insulin resistance between and within study arms
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample.
Beta cell function divided by insulin resistance.
|
from baseline to week 1 and week 4, respectively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
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
|
from baseline to week 1 and week 4, respectively
|
Change in body mass index (BMI)
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).
|
from baseline to week 1 and week 4, respectively
|
Change in waist circumference
Time Frame: from baseline to week 1 and week 4, respectively
|
Measured three times to the nearest millimeter using a non-elastic measuring tape
|
from baseline to week 1 and week 4, respectively
|
Change in bio impedance
Time Frame: from baseline to week 1 and week 4, respectively
|
Tanita MC 780MA segmental multi frequency body composition analyzer
|
from baseline to week 1 and week 4, respectively
|
Change in subscapular and triceps skinfolds
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
|
from baseline to week 1 and week 4, respectively
|
Change in free amino acids in plasma
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in height
Time Frame: from baseline to week 1 and week 4, respectively
|
Height is measured three times to the nearest millimeter using a stadiometer
|
from baseline to week 1 and week 4, respectively
|
Change in blood pressure
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
|
from baseline to week 1 and week 4, respectively
|
Change in pulse rate
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
|
from baseline to week 1 and week 4, respectively
|
Change in appetite hormones
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample: leptin
|
from baseline to week 1 and week 4, respectively
|
Change in appetite hormones
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample: adiponectin
|
from baseline to week 1 and week 4, respectively
|
Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks)
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in bone specific alkaline phosphatase
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in osteocalcin
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in genetics
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
|
from baseline to week 1 and week 4, respectively
|
Change in metabolomics related to the study outcomes
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Change in proteomics related to the study outcomes
Time Frame: from baseline to week 1 and week 4, respectively
|
Blood sample
|
from baseline to week 1 and week 4, respectively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Mølgaard, professor, Department of Nutrition, Exercise and Sports, University of Copenhagen
- Study Chair: Benedikte Grenov, postdoc, Department of Nutrition, Exercise and Sports, University of Copenhagen
- Study Chair: Anni Larnkjær, PhD, Department of Nutrition, Exercise and Sports, University of Copenhagen
- Study Chair: Camilla T. Damsgaard, Associate Professor, Department of Nutrition, Exercise and Sports, University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth Acceleration
-
University of California, DavisCompletedGrowth Acceleration | Growth RetardationUnited States
-
Société des Produits Nestlé (SPN)Completed
-
Bright Dairy & Food Co., LtdCompleted
-
Ethiopian Public Health InstituteWageningen University; Micronutrient InitiativeCompletedGrowth Acceleration | Infant MorbidityEthiopia
-
Ege UniversityBuca Women Birth and Child Diseases HospitalCompletedGrowth Acceleration | Development, Infant | Breastfeeding, Exclusive | AttachmentTurkey
-
NEOCOSURUnknown
-
University of IcelandHarvard Medical School (HMS and HSDM); Massachusetts General Hospital; University...CompletedAdiposity | Body Composition, Beneficial | Growth Acceleration
-
Beni-Suef UniversityRecruitingAcceleration of Tooth MovementEgypt
-
Cairo UniversityRecruitingOrthodontics | Platelet-Rich Fibrin | AccelerationEgypt
-
Jordan University of Science and TechnologyCompletedPiezocision | Acceleration of Tooth Movement
Clinical Trials on 35 g protein (30% milk + 70% rapeseed)
-
University of AarhusArla Foods; Mejeribrugets ForskningsFond; Innovation foundationCompletedProtein MetabolismDenmark
-
Purdue UniversityCompleted
-
Nantes University HospitalTerminated
-
Lindenwood UniversityCompletedAmino Acid AbsorptionUnited States
-
Pennington Biomedical Research CenterCompleted
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesJordan
-
University of AarhusUniversity of CopenhagenRecruitingInflammatory Bowel Diseases | Colitis, Ulcerative | Magnesium Deficiency | Nutritional Deficiency | Protein DeficiencyDenmark
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesIsrael
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesPoland
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesIran, Islamic Republic of