Body Height, Bone Density Increased
Conditions
Keywords
milk, bone health, body growth, young children
Brief summary
Objectives: to examine the effects of a Yili child formula milk and regular milk on bone health and growth in young children. Study design: cluster randomized controlled trial. Setting: kindergartens in Hui-ning County of Gansu Province, China (north west). Participants: \>=246 apparent healthy children aged 4-6 years old. Interventions: (I) Yili child formula milk (QQ star formula, SCI-PRO NUTR5+6TM), 195 ml \*2 /day; (II) Yili regular milk (pure milk), 195ml\*2 /day; (III) Controls: about 50g/d grain foods (containing 20-30 g carbohydrates), e.g. bread. Interventional Duration: 12 months. Outcome measures: determined at 0, 6 and 12 months post treatments. Primary outcomes: bone density and bone mineral contents at the forearm and heel, bone biomarkers. Secondary outcomes: (1) anthropometric indices: weight, height, waist circumference, etc.; (2) immune status. Other measures: dietary intakes, physical activities, general information, medical information, adverse of side effects. Data Analyses: The one-year changes and percent changes in the primary and secondary outcomes will be compared among the 3 groups.
Interventions
DIETARY_SUPPLEMENTFormula milk
Brand name: Yili (QQ star formula milk); Type: SCI-PRO NUTRI 5+6TM formula milk designed for young children aged over 3 years; Dosage: 195ml\*2/d; Intervention duration: 12 months
DIETARY_SUPPLEMENTRegular milk
Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml\*2/d; Intervention duration: 12 months
OTHERControl foods
Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g \* 2/d grain foods Intervention duration: 12 months
Sponsors
LanZhou University
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The two milk products have the same-looking package and similar taste.
Eligibility
Sex/Gender
ALL
Age
48 Months to 83 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged between 4-6 years; * female and male * Can be enrolled into kindergarten/school as a normal child. * Be willing to drinking milk daily.
Exclusion criteria
* Milk allergy or intolerance, did not to be used to drinking milk; * Had the following diseases/conditions confirmed by a hospital: serious diseases of heart, liver, kidney, brain, hematopoietic system, immunity, thyroid or cancer that need to be hospitalization for more than 1 week or take medication(s) for more than 1 month with the past two years. * having infectious diseases, e.g., tuberculosis, hepatitis, etc. * Taking vitamin D, calcium tables or nutrient package; * Consumed more than 3 times (\>600ml) milk each week in the previous month. * Be not willing to provide informed consent, or have other conditions that were considered to be unsuitable for the study by the investigators. * Increases of body health were out of the range between 5-8 cm in the last year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline bone mineral density (BMD) at 12 months | 0 and 12 months | BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel |
| Change from baseline of tartrate resistant acid phosphatase at 6 months | 0 and 6 months | Bone turnover marker 4: tartrate resistant acid phosphatase |
| Change from baseline of tartrate resistant acid phosphatase at 12 months | 0 and 12 months | Bone turnover marker 4: tartrate resistant acid phosphatase |
| Change from baseline of C-terminal telopeptide of type I collagen at 6 months | 0 and 6 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen |
| Change from baseline of C-terminal telopeptide of type I collagen at 12 months | 0 and 12 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen |
| Change from baseline of osteocalcin at 6 months | 0 and 6 months | Bone turnover marker 2: osteocalcin |
| Change from baseline of osteocalcin at 12 months | 0 and 12 months | Bone turnover marker 2: osteocalcin |
| Change from baseline of bone-specific alkaline phosphatase at 6 months | 0 and 6 months | Bone turnover marker 1: Bone-specific alkaline phosphatase |
| Change from baseline of bone-specific alkaline phosphatase at 12 months | 0 and 12 months | Bone turnover marker 1: Bone-specific alkaline phosphatase |
| Change from baseline bone mineral contents (BMC) at 6 months | 0 and 6 months | BMC (g) determined by DXA at the left forearm and heel. |
| Change from baseline bone mineral contents (BMC) at 12 months | 0 and 12 months | BMC (g) determined by DXA at the left forearm and heel. |
| Change from baseline bone mineral density (BMD) at 6 months | 0 and 6 months | BMD (g/cm2) determined by DXA at the left forearm and heel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline biomarker of body growth at 12 months | 0 and 12 months | Biomarker of body growth: insulin-like growth factor 1 |
| Change from baseline body weight at 12 months | 0 and 12 months | Anthropometric indices: body weight |
| Change from baseline body height at 12 months | 0 and 12 months | Anthropometric indices: body height |
| Change from baseline immune globulin M (Ig M）at 12 months | 0 and 12 months | Immune status: Blood Ig M |
| Change from baseline immune globulin G (Ig G）at 12 months | 0 and 12 months | Immune status: Blood Ig G |
| Change from baseline immune globulin G (Ig A）at 12 months | 0 and 12 months | Immune status: Blood Ig A |
| Change from baseline whit blood cell at 12 months | 0 and 12 months | Immune status: whit blood cell |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status 1: Body weight | 0, 4, 8 and 12 months | Body weight (in kg) |
| Concentrations of blood parathyroid Hormone (PTH) | 0, 6 and 12 months | Serum PTH |
| Physical activity | 0, 4, 8 and 12 months | Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire |
| Child behaviors | 0 and 12 months | Child behaviours: assessed by using a Child behavior Questionnaire-- parent version. The minimum and maximum values: 26-78; higher scores mean worse outcome. |
| Number of participants with treatment-related adverse events | 0, 4, 8 and 12 months | Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake |
| Consumption of dietary calcium | 0, 4, 8 and 12 months | Consumption of dietary calcium (in mg/d) |
| Consumption of dietary protein | 0, 4, 8 and 12 months | Consumption of dietary protein (in g/d) |
| Consumption of dietary energy | 0, 4, 8 and 12 months | Consumption of dietary energy (in kcal/d) |
| Concentrations of serum calcium | 0, 6 and 12 months | Serum calcium (mmol/L) |
| Total consumption of milk and dairy food | 0, 4, 8 and 12 months | Total consumption of milk and dairy food (in ml/d) |
| Nutritional status 4: skinfold thickness | 0, 4, 8 and 12 months | Skinfold thickness (in mm) |
| Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD) | 0, 6 and 12 months | Serum 25-OH-VD |
| Nutritional status 3: middle-arm circumference | 0, 4, 8 and 12 months | Middle-arm circumference (in cm) |
| Nutritional status 2: waist circumference | 0, 4, 8 and 12 months | Waist circumference (in cm) |
Countries
China
Outcome results
None listed