D-pro: Effects of Milk Protein and Vitamin D on Children's Growth and Health

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT03956732

Collaborator

University of Aarhus (Other), Arla Foods (Industry), Arla Foods Ingredients (Other)

200

Enrollment

Location

Arms

9.5

Actual Duration (Months)

21.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of D-pro is to investigate the combined and separate effects of milk protein and vitamin D on bone health, growth, muscle function, body composition and cardiometabolic health in 6-8-year-old children.

Condition or Disease	Intervention/Treatment	Phase
Bone Health Muscle Function Cardiometabolic Health Appetite Regulation	Dietary Supplement: Milk Protein (high) Dietary Supplement: Vitamin D Dietary Supplement: Milk Protein (medium)	N/A

Detailed Description

The D-pro study investigates the effects of high or medium intakes of milk protein, and vitamin D supplements or placebo, in healthy 6-8 year-old Danish children. The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to receive yoghurt products with either high or medium protein content (300g/day, 6 days/week) and to receive tablets with either vitamin D (20 μg/day) or placebo for 24 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.

The primary outcome will be bone mineral density (BMD). The investigators will also measure effects on children's muscle function, cardiometabolic health, body composition, growth and growth factors, nutrient status, immune defence and risk of acute respiratory tract infections, as well as appetite hormones. The investigators will also assess potential sex-specific effects and the potential modifying effect of genotype.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

D-pro will be double-blinded in respect to D vitamin supplementation or placebo, whereas the allocation of yoghurt with high versus medium milk protein content will not be blinded.

Primary Purpose:

Prevention

Official Title:

Effects of Milk Protein and Vitamin D on Children's Growth and Health (D-pro)

Actual Study Start Date :

Jun 20, 2019

Actual Primary Completion Date :

Apr 3, 2020

Actual Study Completion Date :

Apr 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High protein yoghurt and vitamin D supplement Subjects will receive high protein yoghurt and vitamin D tablets.	Dietary Supplement: Milk Protein (high) High protein yoghurt which contains approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week. Dietary Supplement: Vitamin D One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
Experimental: High protein yoghurt and placebo supplement Subjects will receive high protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.	Dietary Supplement: Milk Protein (high) High protein yoghurt which contains approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.
Experimental: Medium protein yoghurt and vitamin D supplement Subjects will receive medium protein yoghurt and vitamin D tablets.	Dietary Supplement: Vitamin D One daily tablet containing 20 μg of vitamin D3, cholecalciferol. Dietary Supplement: Milk Protein (medium) Ordinary yoghurt containing approx. 3.3 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.
Placebo Comparator: Medium protein yoghurt and placebo supplement Subjects will receive medium protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.	Dietary Supplement: Milk Protein (medium) Ordinary yoghurt containing approx. 3.3 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.

Outcome Measures

Primary Outcome Measures

Bone Mineral Density (BMD) [24 weeks]
Measured by dual energy x-ray absorptiometry (DXA)

Secondary Outcome Measures

Bone Mineral Content (BMC) [24 weeks]
by DXA
Fat mass index [24 weeks]
by DXA
Fat free mass index [24 weeks]
by DXA
Bone area [24 weeks]
by DXA
Height [24 weeks]
by stadiometer
Waist circumference [24 weeks]
Insulin-like Growth Factor 1 (IGF-1) [24 weeks]
by fasting blood sample
Insulin-like growth factor-binding protein 3 (IGFBP-3) [24 weeks]
by fasting blood sample
Serum calcium [24 weeks]
by fasting blood sample
Osteocalcin [24 weeks]
by fasting blood sample
Parathyroid hormone (PTH) [24 weeks]
by fasting blood sample
Bone-specific alkaline phosphatase [24 weeks]
by fasting blood sample
C-terminal telopeptide of type 1 collagen in serum (s-CTX) [24 weeks]
by fasting blood sample
Maximal leg press strength [24 weeks]
Measured by isometric leg press
Maximal jumping height [24 weeks]
Measured by squat jump with linear encoder
Maximal jumping length [24 weeks]
Measured by standing long jump
Maximal grip strength [24 weeks]
Measured by hand grip dynamometer
Muscle endurance [24 weeks]
Measured by 30 sec. sit-to-stand
Blood pressure [24 weeks]
Hemoglobin A1c (HbA1c) [24 weeks]
by fasting blood sample
Glucose [24 weeks]
by fasting blood sample
Insulin [24 weeks]
by fasting blood sample
Total cholesterol [24 weeks]
by fasting blood sample
High density lipoprotein cholesterol (HDL cholesterol) [24 weeks]
by fasting blood sample
Low density lipoprotein cholesterol (LDL cholesterol) [24 weeks]
by fasting blood sample
Triacylglycerol (TG) [24 weeks]
by fasting blood sample

Other Outcome Measures

Physical activity [24 weeks]
by accelerometry
C-peptide [24 weeks]
by fasting blood sample
Vitamin D binding protein [24 weeks]
by fasting blood sample
Serum 25(OH) vitamin D [24 weeks]
by fasting blood sample
1,25(OH)2vitamin D [24 weeks]
by fasting blood sample
Urea [24 weeks]
by fasting blood sample
Interleukin-6 (IL-6) [24 weeks]
by fasting blood sample
Interleukin-1β (IL-1β) [24 weeks]
by fasting blood sample
Tumor necrosis factor a (TNF-a) [24 weeks]
by fasting blood sample
Leptin [24 weeks]
by fasting blood sample
Adiponectin [24 weeks]
by fasting blood sample
High sensitivity C-reactive protein (hsCRP) [24 weeks]
by fasting blood sample
Immune cell counts [24 weeks]
by fasting blood sample
Immuno-active peptides in nasal fluid [24 weeks]
by nasal fluid sample
Immuno-active peptides in blood [24 weeks]
by fasting blood sample
Respiratory tract infections [24 weeks]
by questionnaires
Dietary intake [24 weeks]
By 4-day dietary record
Vitamin D and calcium intake [24 weeks]
By food frequency questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children must:

Be 6-8 years of age at the start of the intervention
Be healthy
Have a frequent intake of milk and yoghurt products, corresponding to at least ¼ liter a day
Like yoghurt and high protein yoghurt ("skyr")
Be of white, Danish or European origin

Moreover:

The family must not be planning a winter vacation south of a latitude of 50° North
The child must speak and understand Danish in order to understand the study procedures
At least one parent must read, speak and write Danish

Exclusion Criteria:

Known or suspected allergy or intolerance to milk or milk components
Chronic illness or disease that may affect study outcomes
Chronic intake of medicine that may affect study outcomes
Use of vitamin D-containing supplements >3 days/week the 2 last months and use of any vitamin D-containing supplements the last 1 month before intervention start
Concomitant participation in other studies involving dietary supplements or blood sampling
Living in a household with another participating child

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg		Denmark

Sponsors and Collaborators

University of Copenhagen
University of Aarhus
Arla Foods
Arla Foods Ingredients

Investigators

Principal Investigator: Camilla T Damsgaard, Assoc Prof, Department of Nutrition, Exercise and sports, University of Copenhagen
Study Chair: Christian Mølgaard, Prof, Department of Nutrition, Exercise and sports, University of Copenhagen
Study Chair: Mette Hansen, Assoc Prof, Institute of Public Health, Aarhus University, Denmark