Clinical trial NCT03695328: Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children
Official title: Effect of Nutrition and Physical Activity on Bone Status in 6-12 Years Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Status
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.

Brief summary: Peak bone mass acquisition through childhood and adolescence has been associated with lower risk of osteopenia and osteoporosis in the elderly. The main factors that influence bone mass are the non-modifiable, such as genetics, ethnicity and sex, and the modifiable ones which are nutrition and physical activity or exercise. In the literature are references that demonstrates positive effects of high physical activity, adequate intakes of macro- and micronutrients on bone mass both in adults and in children. Bone mineralization is more adaptive in childrens' growing bones and this is an opportunity for stronger effects by mechanical stimuli during physical activity. The presence of a diet complete of nutrient intakes seems to strengthen the effects of mechanical loads on bone growth and mineralization. The present trial aimed to evaluate the effects of physical activity and nutrition intakes on bone mass in pre-pubertal children.

Detailed description: The sample of this study was healthy pre-pubertal boys and girls (N=210) who had training age 0-1 years. Data collection included anthropometric measurements, blood sampling, body composition, bone measurements and physical performance measurements. Nutritional intake was recorded for seven consecutive days in order to evaluate nutrient intakes using an appropriate software and habitual physical activity was measured for the same days using accelerometers. Pubertal stage determined by Tanner scale. All measurements were made only once at the beginning of school year.

Eligibility criteria: Inclusion Criteria:

* were 6-12 years and pre-pubertal
* were healthy and had no prior bone fractures or related surgical operation
* their body fat was \<30%, e) had no history of growth irregularities
* were not receiving agents or drugs that affect bone tissue (e.g. Gonadotropin-Releasing Hormone (GnRH) agonists, antiresorptive, bisphosphonates, etc.)

Exclusion Criteria:

* had prior bone fractures or related surgical operation
* their body fat was \>30%
* had history of growth irregularities
* were receiving agents or drugs that affect bone tissue (e.g. GnRH agonists, antiresorptive, bisphosphonates, etc.)

Primary outcomes:
measure: Whole body bone mineral density
timeFrame: 1 day (Once)
measure: Lumbar spine bone mineral density
timeFrame: 1 day (Once)
measure: Hips bone mineral density
timeFrame: 1 day (Once)
measure: Whole body mineral content
timeFrame: 1 day (Once)
measure: Lumbar spine bone mineral content
timeFrame: 1 day (Once)
measure: Hips bone mineral content
timeFrame: 1 day (Once)
measure: Body composition
timeFrame: 1 day (Once)
measure: Muscular strength
timeFrame: 1 day (Once)
measure: Cardiovascular endurance
timeFrame: 1 day (Once)
measure: Flexibility
timeFrame: 1 day (Once)
Secondary outcomes:
measure: Sclerostin
timeFrame: 1 day (Once)
measure: Serum vitamin D
timeFrame: 1 day (Once)
measure: Serum calcium
timeFrame: 1 day (Once)
measure: Pubertal Stage
timeFrame: 1 day (Once)
Other outcomes:
Locations:
Study officials:
affiliation: Democritus University of Thrace, Department of Physical Education & Sports Sciencies
name: Theodoros Stampoulis, PhD student
role: PRINCIPAL_INVESTIGATOR
References: