NCT Number: NCT03695328
Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children
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.
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About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.)
Treatment and study plan
Dietary Intake
BehavioralPrimary outcomes
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Whole body bone mineral density
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
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Lumbar spine bone mineral density
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
-
Hips bone mineral density
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
-
Whole body mineral content
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
-
Lumbar spine bone mineral content
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
-
Hips bone mineral content
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
-
Body composition
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry and skinfolds
-
Muscular strength
Time frame: 1 day (Once)
Handgrip strength
-
Cardiovascular endurance
Time frame: 1 day (Once)
20m shuttle run test
-
Flexibility
Time frame: 1 day (Once)
Sit and reach test
Secondary outcomes
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Sclerostin
Time frame: 1 day (Once)
Measured in blood samples with an appropriate kit
-
Serum vitamin D
Time frame: 1 day (Once)
Measured in blood smaples
-
Serum calcium
Time frame: 1 day (Once)
Measured in blood smaples
-
Pubertal Stage
Time frame: 1 day (Once)
Evaluated with Tanner Stage protocol
Sponsors and collaborators
Lead sponsor
Democritus University of Thrace
Other
Registry information
Official study title
Effect of Nutrition and Physical Activity on Bone Status in 6-12 Years Children
Acronym: Nutri-Bone
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2018
- First posted
- Oct 4, 2018
- Registry last updated
- Oct 4, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.