Growth Acceleration, Growth; Stunting, Nutritional
Conditions
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)
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).
Interventions
DIETARY_SUPPLEMENT35 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_SUPPLEMENT35 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_SUPPLEMENT35 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.
Sponsors
Arla Foods
University of Aarhus
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study is a randomized, controlled, double-blind, parallel food intervention study with 3 study arms
Eligibility
Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IGF-I between study arms | from baseline to week 4 | Blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IGF-1 between and within study arms | from baseline to week 1 | Blood sample |
| Change in IGFBP-3 between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in the ratio IGF-1/IGFBP-3 between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample. Concentration of IGF-1 divided by the concentration of IGFBP-3. |
| Change in IGF-1 within study arms | from baseline to week 4 | Blood sample |
| Change in relative insulin resistance between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in beta cell function between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in beta cell function/insulin resistance between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample. Beta cell function divided by insulin resistance. |
| Change in insulin between and within study arms | from baseline to week 1 and week 4, respectively | Blood sample |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in appetite hormones | from baseline to week 1 and week 4, respectively | Blood sample: leptin |
| Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks) | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in bone specific alkaline phosphatase | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in weight | from baseline to week 1 and week 4, respectively | The weight is measured once on a digital weighing scale (Tanita MC 780) in kg |
| Change in genetics | 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 |
| Change in metabolomics related to the study outcomes | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in proteomics related to the study outcomes | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in osteocalcin | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in body mass index (BMI) | 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). |
| Change in waist circumference | from baseline to week 1 and week 4, respectively | Measured three times to the nearest millimeter using a non-elastic measuring tape |
| Change in bio impedance | from baseline to week 1 and week 4, respectively | Tanita MC 780MA segmental multi frequency body composition analyzer |
| Change in subscapular and triceps skinfolds | 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 |
| Change in free amino acids in plasma | from baseline to week 1 and week 4, respectively | Blood sample |
| Change in height | from baseline to week 1 and week 4, respectively | Height is measured three times to the nearest millimeter using a stadiometer |
| Change in blood pressure | 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 |
| Change in pulse rate | 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 |
Countries
Denmark
Outcome results
None listed