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

University of Copenhagen200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Bone Health Muscle Function Cardiometabolic Health Appetite Regulation

Interventions

Milk Protein (high)DIETARY_SUPPLEMENT

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.

Vitamin DDIETARY_SUPPLEMENT

One daily tablet containing 20 μg of vitamin D3, cholecalciferol.

Milk Protein (medium)DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

Outcomes

Primary Outcomes

Bone Mineral Density (BMD)

Measured by dual energy x-ray absorptiometry (DXA)

Time frame: 24 weeks

Secondary Outcomes

Bone Mineral Content (BMC)

by DXA

Time frame: 24 weeks

Fat mass index

by DXA

Time frame: 24 weeks

Fat free mass index

by DXA

Time frame: 24 weeks

Bone area

by DXA

Time frame: 24 weeks

Height

by stadiometer

Time frame: 24 weeks

Waist circumference

Time frame: 24 weeks

Insulin-like Growth Factor 1 (IGF-1)

by fasting blood sample

Time frame: 24 weeks

Insulin-like growth factor-binding protein 3 (IGFBP-3)

by fasting blood sample

Time frame: 24 weeks

Serum calcium

by fasting blood sample

Time frame: 24 weeks

Osteocalcin

Data from ClinicalTrials.gov

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