Bone StatusNutri-BoneNCT03695328
Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children
An observational study of Bone Status, run by Democritus University of Thrace.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Status
- What is being tested?
- physical activity level and Dietary Intake
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to 15 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.
Who may be able to join
- 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.)
Who cannot join
- 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.)
About this study
Official title: 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.
Read the 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
- Being tested
- physical activity level, Dietary Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity levelBehavioural
Dietary IntakeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Dietary Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body bone mineral density
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Lumbar spine bone mineral density
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Hips bone mineral density
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Whole body mineral content
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Lumbar spine bone mineral content
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Hips bone mineral content
Measured by Dual-X-ray Absoroptiometry
Measured: 1 day (Once)
Body composition
Measured by Dual-X-ray Absoroptiometry and skinfolds
Measured: 1 day (Once)
Muscular strength
Handgrip strength
Measured: 1 day (Once)
Cardiovascular endurance
20m shuttle run test
Measured: 1 day (Once)
Flexibility
Sit and reach test
Measured: 1 day (Once)
Secondary outcomes (4)
Sclerostin
Measured in blood samples with an appropriate kit
Measured: 1 day (Once)
Serum vitamin D
Measured in blood smaples
Measured: 1 day (Once)
Serum calcium
Measured in blood smaples
Measured: 1 day (Once)
Pubertal Stage
Evaluated with Tanner Stage protocol
Measured: 1 day (Once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start15 Sep 2015
- Primary completion25 Oct 2015
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAMBAS ANTONIS, Democritus University of Thrace
- Investigators
- Theodoros Stampoulis, PhD student, Principal investigator, Democritus University of Thrace, Department of Physical Education & Sports Sciencies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695328
- Sponsor's protocol ID
- Nutri-Bone DUTH
- Acronym
- Nutri-Bone
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition and Physical Activity on Bone Status in 6-12 Years Children
- ClinicalTrials.gov ID
- NCT03695328
- Acronym / sponsor ID
- Nutri-Bone / Nutri-Bone DUTH
- Conditions
- Bone Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 25 Oct 2015 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical activity level | – | Behavioral: physical activity levelChildren categorized either in the group with moderate to vigorous physical activity or in the group with low physical activity according the accelerometer's measures |
| dietary intake | – | Behavioral: Dietary IntakeChildrens' 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity level | Behavioural | physical activity level |
| Dietary Intake | Behavioural | dietary intake |
Primary outcome
Whole body bone mineral density
Time frame: 1 day (Once)
Measured by Dual-X-ray Absoroptiometry
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
4 secondary outcomes
Sclerostin
Time frame: 1 day (Once)
Serum vitamin D
Time frame: 1 day (Once)
Serum calcium
Time frame: 1 day (Once)
Pubertal Stage
Time frame: 1 day (Once)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodoros Stampoulis, PhD student principal investigator
Democritus University of Thrace, Department of Physical Education & Sports Sciencies
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Status, run by Democritus University of Thrace.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body bone mineral density (time frame: 1 day (Once)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.