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

Bone Health Clinical Trial

— D-pro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956732
• Other study ID #: D224
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: April 3, 2020

Study information

• Verified date: April 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite Regulation
• Bone Health
• Cardiometabolic Health
• Muscle Function

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, Arla Foods Ingredients, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	by accelerometry	24 weeks
Other	C-peptide	by fasting blood sample	24 weeks
Other	Vitamin D binding protein	by fasting blood sample	24 weeks
Other	Serum 25(OH) vitamin D	by fasting blood sample	24 weeks
Other	1,25(OH)2vitamin D	by fasting blood sample	24 weeks
Other	Urea	by fasting blood sample	24 weeks
Other	Interleukin-6 (IL-6)	by fasting blood sample	24 weeks
Other	Interleukin-1ß (IL-1ß)	by fasting blood sample	24 weeks
Other	Tumor necrosis factor a (TNF-a)	by fasting blood sample	24 weeks
Other	Leptin	by fasting blood sample	24 weeks
Other	Adiponectin	by fasting blood sample	24 weeks
Other	High sensitivity C-reactive protein (hsCRP)	by fasting blood sample	24 weeks
Other	Immune cell counts	by fasting blood sample	24 weeks
Other	Immuno-active peptides in nasal fluid	by nasal fluid sample	24 weeks
Other	Immuno-active peptides in blood	by fasting blood sample	24 weeks
Other	Respiratory tract infections	by questionnaires	24 weeks
Other	Dietary intake	By 4-day dietary record	24 weeks
Other	Vitamin D and calcium intake	By food frequency questionnaire	24 weeks
Primary	Bone Mineral Density (BMD)	Measured by dual energy x-ray absorptiometry (DXA)	24 weeks
Secondary	Bone Mineral Content (BMC)	by DXA	24 weeks
Secondary	Fat mass index	by DXA	24 weeks
Secondary	Fat free mass index	by DXA	24 weeks
Secondary	Bone area	by DXA	24 weeks
Secondary	Height	by stadiometer	24 weeks
Secondary	Waist circumference		24 weeks
Secondary	Insulin-like Growth Factor 1 (IGF-1)	by fasting blood sample	24 weeks
Secondary	Insulin-like growth factor-binding protein 3 (IGFBP-3)	by fasting blood sample	24 weeks
Secondary	Serum calcium	by fasting blood sample	24 weeks
Secondary	Osteocalcin	by fasting blood sample	24 weeks
Secondary	Parathyroid hormone (PTH)	by fasting blood sample	24 weeks
Secondary	Bone-specific alkaline phosphatase	by fasting blood sample	24 weeks
Secondary	C-terminal telopeptide of type 1 collagen in serum (s-CTX)	by fasting blood sample	24 weeks
Secondary	Maximal leg press strength	Measured by isometric leg press	24 weeks
Secondary	Maximal jumping height	Measured by squat jump with linear encoder	24 weeks
Secondary	Maximal jumping length	Measured by standing long jump	24 weeks
Secondary	Maximal grip strength	Measured by hand grip dynamometer	24 weeks
Secondary	Muscle endurance	Measured by 30 sec. sit-to-stand	24 weeks
Secondary	Blood pressure		24 weeks
Secondary	Hemoglobin A1c (HbA1c)	by fasting blood sample	24 weeks
Secondary	Glucose	by fasting blood sample	24 weeks
Secondary	Insulin	by fasting blood sample	24 weeks
Secondary	Total cholesterol	by fasting blood sample	24 weeks
Secondary	High density lipoprotein cholesterol (HDL cholesterol)	by fasting blood sample	24 weeks
Secondary	Low density lipoprotein cholesterol (LDL cholesterol)	by fasting blood sample	24 weeks
Secondary	Triacylglycerol (TG)	by fasting blood sample	24 weeks