Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children

NCT ID: NCT03695328

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2018-05-15

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.

Conditions

Bone Status

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

physical activity level

Children categorized either in the group with moderate to vigorous physical activity or in the group with low physical activity according the accelerometer's measures

physical activity level

Intervention Type: BEHAVIORAL

dietary intake

Childrens' 24th dietary recalls for 7 days analyzed for protein, calcium, vitamin D and phosphorus intake and they categorized according the RDAs above or below them.

Dietary Intake

Intervention Type: BEHAVIORAL

Interventions

physical activity level

Intervention Type: BEHAVIORAL

Dietary Intake

Intervention Type: BEHAVIORAL

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.)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

KAMBAS ANTONIS

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodoros Stampoulis, PhD student

Role: PRINCIPAL_INVESTIGATOR

Democritus University of Thrace, Department of Physical Education & Sports Sciencies

Other Identifiers

Nutri-Bone DUTH

Identifier Type: -

Identifier Source: org_study_id