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

October 3, 2018 updated by: KAMBAS ANTONIS, Democritus University of Thrace

Effect of Nutrition and Physical Activity on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Behavioral: physical activity level
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.
Behavioral: Dietary Intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole body bone mineral density
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Lumbar spine bone mineral density
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Hips bone mineral density
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Whole body mineral content
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Lumbar spine bone mineral content
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Hips bone mineral content
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
1 day (Once)
Body composition
Time Frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry and skinfolds
1 day (Once)
Muscular strength
Time Frame: 1 day (Once)
Handgrip strength
1 day (Once)
Cardiovascular endurance
Time Frame: 1 day (Once)
20m shuttle run test
1 day (Once)
Flexibility
Time Frame: 1 day (Once)
Sit and reach test
1 day (Once)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sclerostin
Time Frame: 1 day (Once)
Measured in blood samples with an appropriate kit
1 day (Once)
Serum vitamin D
Time Frame: 1 day (Once)
Measured in blood smaples
1 day (Once)
Serum calcium
Time Frame: 1 day (Once)
Measured in blood smaples
1 day (Once)
Pubertal Stage
Time Frame: 1 day (Once)
Evaluated with Tanner Stage protocol
1 day (Once)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Principal Investigator: Theodoros Stampoulis, PhD student, Democritus University of Thrace, Department of Physical Education & Sports Sciencies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2015

Primary Completion (Actual)

October 25, 2015

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Nutri-Bone DUTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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