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OpenTrials
Completed

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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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

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

physical activity level

Behavioral

Dietary Intake

Behavioral

Primary outcomes

  1. Whole body bone mineral density

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  2. Lumbar spine bone mineral density

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  3. Hips bone mineral density

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  4. Whole body mineral content

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  5. Lumbar spine bone mineral content

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  6. Hips bone mineral content

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry

  7. Body composition

    Time frame: 1 day (Once)

    Measured by Dual-X-ray Absoroptiometry and skinfolds

  8. Muscular strength

    Time frame: 1 day (Once)

    Handgrip strength

  9. Cardiovascular endurance

    Time frame: 1 day (Once)

    20m shuttle run test

  10. Flexibility

    Time frame: 1 day (Once)

    Sit and reach test

Secondary outcomes

  1. Sclerostin

    Time frame: 1 day (Once)

    Measured in blood samples with an appropriate kit

  2. Serum vitamin D

    Time frame: 1 day (Once)

    Measured in blood smaples

  3. Serum calcium

    Time frame: 1 day (Once)

    Measured in blood smaples

  4. 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.