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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
| University of Aarhus | OTHER |
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The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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):
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IGF-I between study arms | Blood sample | from baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IGF-1 within study arms | Blood sample | from baseline to week 4 |
| Change in IGF-1 between and within study arms | Blood sample |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | 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) | 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). |
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
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports | Copenhagen | Frederiksberg | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34333391 | Result | 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. |
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The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
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|
| 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):
|
|
| 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):
|
|
| from baseline to week 1 |
| Change in IGFBP-3 between and within study arms | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in the ratio IGF-1/IGFBP-3 between and within study arms | 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 | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in relative insulin resistance between and within study arms | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in beta cell function between and within study arms | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in beta cell function/insulin resistance between and within study arms | Blood sample. Beta cell function divided by insulin resistance. | from baseline to week 1 and week 4, respectively |
| from baseline to week 1 and week 4, respectively |
| Change in waist circumference | 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 | Tanita MC 780MA segmental multi frequency body composition analyzer | from baseline to week 1 and week 4, respectively |
| Change in subscapular and triceps skinfolds | 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 | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in height | 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 | 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 | 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 | Blood sample: leptin | from baseline to week 1 and week 4, respectively |
| Change in appetite hormones | 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) | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in bone specific alkaline phosphatase | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in osteocalcin | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in genetics | 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 | Blood sample | from baseline to week 1 and week 4, respectively |
| Change in proteomics related to the study outcomes | Blood sample | from baseline to week 1 and week 4, respectively |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| D008892 | Milk |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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