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| Name | Class |
|---|---|
| LanZhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula Milk | Experimental | Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
|
| Regular milk | Active Comparator | Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
|
| Control foods | Other | Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula milk | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline bone mineral density (BMD) at 12 months | BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel | 0 and 12 months |
| Change from baseline bone mineral density (BMD) at 6 months | BMD (g/cm2) determined by DXA at the left forearm and heel | 0 and 6 months |
| Change from baseline bone mineral contents (BMC) at 12 months | BMC (g) determined by DXA at the left forearm and heel. | 0 and 12 months |
| Change from baseline bone mineral contents (BMC) at 6 months | BMC (g) determined by DXA at the left forearm and heel. | 0 and 6 months |
| Change from baseline of bone-specific alkaline phosphatase at 12 months | Bone turnover marker 1: Bone-specific alkaline phosphatase | 0 and 12 months |
| Change from baseline of bone-specific alkaline phosphatase at 6 months | Bone turnover marker 1: Bone-specific alkaline phosphatase | 0 and 6 months |
| Change from baseline of osteocalcin at 12 months | Bone turnover marker 2: osteocalcin | 0 and 12 months |
| Change from baseline of osteocalcin at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline body weight at 12 months | Anthropometric indices: body weight | 0 and 12 months |
| Change from baseline body height at 12 months | Anthropometric indices: body height |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD) | Serum 25-OH-VD | 0, 6 and 12 months |
| Concentrations of blood parathyroid Hormone (PTH) | Serum PTH |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuming Chen, Ph.D. | Sun Yat-sen University | Principal Investigator |
| Zhifu Zhao, M. Phil | Inner Mongolia Dairy Technology Research Institute Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University | Lanzhou | Gangshu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39043915 | Derived | Zhao ZF, Li BY, He Q, Hao JY, Zhang KS, Zhang B, Hu W, Feng HT, Szeto IM, Chen YM, Zhang GX, Tang XY. Impact of dairy supplementation on bone acquisition in children's limbs: a 12-month cluster-randomized controlled trial and meta-analysis. Arch Osteoporos. 2024 Jul 24;19(1):65. doi: 10.1007/s11657-024-01422-2. |
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Published data based on reasonable request.
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| ID | Term |
|---|---|
| D010026 | Osteosclerosis |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The two milk products have the same-looking package and similar taste.
| Regular milk | Dietary Supplement | Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months |
|
| Control foods | Other | Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g * 2/d grain foods Intervention duration: 12 months |
|
Bone turnover marker 2: osteocalcin |
| 0 and 6 months |
| Change from baseline of C-terminal telopeptide of type I collagen at 12 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen | 0 and 12 months |
| Change from baseline of C-terminal telopeptide of type I collagen at 6 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen | 0 and 6 months |
| Change from baseline of tartrate resistant acid phosphatase at 12 months | Bone turnover marker 4: tartrate resistant acid phosphatase | 0 and 12 months |
| Change from baseline of tartrate resistant acid phosphatase at 6 months | Bone turnover marker 4: tartrate resistant acid phosphatase | 0 and 6 months |
| 0 and 12 months |
| Change from baseline biomarker of body growth at 12 months | Biomarker of body growth: insulin-like growth factor 1 | 0 and 12 months |
| Change from baseline immune globulin M (Ig M）at 12 months | Immune status: Blood Ig M | 0 and 12 months |
| Change from baseline immune globulin G (Ig G）at 12 months | Immune status: Blood Ig G | 0 and 12 months |
| Change from baseline immune globulin G (Ig A）at 12 months | Immune status: Blood Ig A | 0 and 12 months |
| Change from baseline whit blood cell at 12 months | Immune status: whit blood cell | 0 and 12 months |
| 0, 6 and 12 months |
| Nutritional status 1: Body weight | Body weight (in kg) | 0, 4, 8 and 12 months |
| Nutritional status 2: waist circumference | Waist circumference (in cm) | 0, 4, 8 and 12 months |
| Nutritional status 3: middle-arm circumference | Middle-arm circumference (in cm) | 0, 4, 8 and 12 months |
| Nutritional status 4: skinfold thickness | Skinfold thickness (in mm) | 0, 4, 8 and 12 months |
| Total consumption of milk and dairy food | Total consumption of milk and dairy food (in ml/d) | 0, 4, 8 and 12 months |
| Consumption of dietary energy | Consumption of dietary energy (in kcal/d) | 0, 4, 8 and 12 months |
| Consumption of dietary protein | Consumption of dietary protein (in g/d) | 0, 4, 8 and 12 months |
| Consumption of dietary calcium | Consumption of dietary calcium (in mg/d) | 0, 4, 8 and 12 months |
| Number of participants with treatment-related adverse events | Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake | 0, 4, 8 and 12 months |
| Child behaviors | Child behaviours: assessed by using a Child behavior Questionnaire-- parent version. The minimum and maximum values: 26-78; higher scores mean worse outcome. | 0 and 12 months |
| Physical activity | Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire | 0, 4, 8 and 12 months |
| Concentrations of serum calcium | Serum calcium (mmol/L) | 0, 6 and 12 months |