Milk Supplementation and Bone Health in Children
Study Details
Study Description
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), 195ml2 /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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Formula Milk Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Dietary Supplement: Formula 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
|
| Active Comparator: Regular milk Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Dietary Supplement: Regular milk
Brand name: Yili；
Type: regular milk (pure milk);
Dosage: 195ml*2/d;
Intervention duration: 12 months
|
| Other: Control foods Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months |
Other: Control foods
Brand: N/A;
Food type: grain foods (e.g., bread);
Dosage: 20-40g * 2/d grain foods
Intervention duration: 12 months
|
Outcome Measures
Primary Outcome Measures
- 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 bone mineral density (BMD) at 6 months [0 and 6 months]
BMD (g/cm2) 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 contents (BMC) at 6 months [0 and 6 months]
BMC (g) determined by DXA at the left forearm and heel.
- 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 of bone-specific alkaline phosphatase at 6 months [0 and 6 months]
Bone turnover marker 1: Bone-specific alkaline phosphatase
- Change from baseline of osteocalcin at 12 months [0 and 12 months]
Bone turnover marker 2: osteocalcin
- Change from baseline of osteocalcin at 6 months [0 and 6 months]
Bone turnover marker 2: osteocalcin
- 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 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 tartrate resistant acid phosphatase at 12 months [0 and 12 months]
Bone turnover marker 4: tartrate resistant acid phosphatase
- Change from baseline of tartrate resistant acid phosphatase at 6 months [0 and 6 months]
Bone turnover marker 4: tartrate resistant acid phosphatase
Secondary Outcome Measures
- 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 biomarker of body growth at 12 months [0 and 12 months]
Biomarker of body growth: insulin-like growth factor 1
- 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 Outcome Measures
- Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD) [0, 6 and 12 months]
Serum 25-OH-VD
- Concentrations of blood parathyroid Hormone (PTH) [0, 6 and 12 months]
Serum PTH
- Nutritional status 1: Body weight [0, 4, 8 and 12 months]
Body weight (in kg)
- Nutritional status 2: waist circumference [0, 4, 8 and 12 months]
Waist circumference (in cm)
- Nutritional status 3: middle-arm circumference [0, 4, 8 and 12 months]
Middle-arm circumference (in cm)
- Nutritional status 4: skinfold thickness [0, 4, 8 and 12 months]
Skinfold thickness (in mm)
- Total consumption of milk and dairy food [0, 4, 8 and 12 months]
Total consumption of milk and dairy food (in ml/d)
- Consumption of dietary energy [0, 4, 8 and 12 months]
Consumption of dietary energy (in kcal/d)
- Consumption of dietary protein [0, 4, 8 and 12 months]
Consumption of dietary protein (in g/d)
- Consumption of dietary calcium [0, 4, 8 and 12 months]
Consumption of dietary calcium (in mg/d)
- 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
- 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.
- Physical activity [0, 4, 8 and 12 months]
Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
- Concentrations of serum calcium [0, 6 and 12 months]
Serum calcium (mmol/L)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged between 4-6 years;
-
female and male
-
Can be enrolled into kindergarten/school as a normal child.
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Be willing to drinking milk daily.
Exclusion Criteria:
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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.
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having infectious diseases, e.g., tuberculosis, hepatitis, etc.
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Taking vitamin D, calcium tables or nutrient package;
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Consumed more than 3 times (>600ml) milk each week in the previous month.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lanzhou University | Lanzhou | Gangshu | China | 730000 |
Sponsors and Collaborators
- Sun Yat-sen University
- LanZhou University
Investigators
- Principal Investigator: Yuming Chen, Ph.D., Sun Yat-sen University
- Study Chair: Zhifu Zhao, M. Phil, Inner Mongolia Dairy Technology Research Institute Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYSU-51000-20210723-0001