Mineral DeficiencyNCT06448858
Minerals Status in Relation to Overweight and Obese Adolescent
An observational study of Mineral Deficiency, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Mineral Deficiency
- What is being tested?
- serum Mn, Se, iron, Cu & Zn levels
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2024to Jun 2025
- How long will I take part?
- 1 Year
- 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 12 to 18 years
- All sexes
- Child, Adult
Study population: Normal,overweight and obese adolescents
Who may be able to join
- Patients in adolescent age (12-18 years old)
- Patients with BMI over 25.
Who cannot join
- Patients younger than 12 years old or older than 18 years old.
- Patients with history of chronic use of mineral and /or vitamin supplements .
- Patients with syndromal obesity , endocrine disorder and history of any chronic diseases ,
- Patients under special diets or chronic use of medication .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Body Composition on Some Blood Minerals Status in Obese and Overweight Adolescent; Cross Sectional Study
Evaluation of the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients.
Read the detailed description
Obesity in the population tends to be a notable public health threat on the global scale . individuals with higher body mass index (BMI) are considered to have a lower life expectancy . Among the obesity-related indicators, visceral adipose tissue (VAT) is acknowledged an emerging and sensitive predictor for the risk of metabolic syndrome and cardiovascular disease . Therefore, adverse VAT accumulation can influence metabolic health in the population, and its related risk factors should be further investigated.
Micronutrients in obese people are explored because of an excess energy consumption, and therefore, an inadequate intake of trace elements and minerals. This imbalance among energy consumption and the intake is known as hidden hunger. Obesity can lead to nutritional metabolic disorders, in which the general state of trace elements and minerals are altered.
Only a few studies on child and adolescents obesity concerned Trace Elements (TE). TE is involved in the pathogenesis of obesity and obesity related diseases. We tried to assess trace elements status [ Manganese (Mn), selenium (Se) copper (Cu),zinc (Zn)] in obese children and their relationships with VAT and metabolic risk factors of obesity.
Manganese (Mn) is an essential trace element . It plays an important role in fat metabolism.
Selenium (Se) is an essential micronutrient that acts as an antioxidant and possesses multiple metabolic properties.
Copper (Cu) is a trace element that is vital. Cu has been reported to play a role in fat metabolism.
Zinc (Zn) plays an important role. Its deficiency impairs growth, metabolism and immunity.
Iron (Fe) is an essential trace element to sustain all forms of life. Existing research indicates iron deficiency is one of the comorbidities associated with obesity .
- Conditions
- Mineral Deficiency
- Being tested
- serum Mn, Se, iron, Cu & Zn levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum Mn, Se, iron, Cu & Zn levelsDiagnostic test
Evaluate the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Patients with BMI more than 30 Receives: Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels | |
| Overweight | Patients with BMI 25-30 Receives: Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels | |
| Control | Patients with BMI less than 25 Receives: Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of serum Manganese
Evaluate the concentration of serum Mn levels in obese and overweight adolescents.
Measured: 1 year
Concentration of serum selenium
Evaluate the concentration of serum Se levels in obese and overweight adolescents.
Measured: 1 year
Concentration of serum Iron
Evaluate the concentration of serum Iron levels in obese and overweight adolescents.
Measured: 1 year
Concentration of serum copper
Evaluate the concentration of serum Cu levels in obese and overweight adolescents.
Measured: 1 year
Concentration of serum Zinc
Evaluate the concentration of serum Zn levels in obese and overweight adolescents.
Measured: 1 year
Secondary outcomes (4)
BMI and its relation to mineral levels
Correlate the BMI with these minerals' concentration.
Measured: 1 year
Visceral fat and it's relation to mineral levels
Correlate Visceral fat with these minerals' concentration.
Measured: 1 year
Basal metabolic rate and it's relation to mineral levels
Correlate basal metabolic rate with these minerals' concentration.
Measured: 1 year
Body fat percentage and it's relation to mineral level
Correlate body fat percentage with these minerals' concentration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mineral DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Hussien Abdelmoneim Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448858
- Sponsor's protocol ID
- Minerals in Adolescent
- Status last verified
- Jun 2024
- First submitted
- 16 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Composition on Some Blood Minerals Status in Obese and Overweight Adolescent; Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06448858
- Acronym / sponsor ID
- Minerals in Adolescent
- Conditions
- Mineral Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Jun 2024 (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.
Evaluation of the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients.
Detailed description
Obesity in the population tends to be a notable public health threat on the global scale . individuals with higher body mass index (BMI) are considered to have a lower life expectancy . Among the obesity-related indicators, visceral adipose tissue (VAT) is acknowledged an emerging and sensitive predictor for the risk of metabolic syndrome and cardiovascular disease . Therefore, adverse VAT accumulation can influence metabolic health in the population, and its related risk factors should be further investigated.
Micronutrients in obese people are explored because of an excess energy consumption, and therefore, an inadequate intake of trace elements and minerals. This imbalance among energy consumption and the intake is known as hidden hunger. Obesity can lead to nutritional metabolic disorders, in which the general state of trace elements and minerals are altered.
Only a few studies on child and adolescents obesity concerned Trace Elements (TE). TE is involved in the pathogenesis of obesity and obesity related diseases. We tried to assess trace elements status [ Manganese (Mn), selenium (Se) copper (Cu),zinc (Zn)] in obese children and their relationships with VAT and metabolic risk factors of obesity.
Manganese (Mn) is an essential trace element . It plays an important role in fat metabolism.
Selenium (Se) is an essential micronutrient that acts as an antioxidant and possesses multiple metabolic properties.
Copper (Cu) is a trace element that is vital. Cu has been reported to play a role in fat metabolism.
Zinc (Zn) plays an important role. Its deficiency impairs growth, metabolism and immunity.
Iron (Fe) is an essential trace element to sustain all forms of life. Existing research indicates iron deficiency is one of the comorbidities associated with obesity .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Diagnostic Test: serum Mn, Se, iron, Cu & Zn levelsPatients with BMI more than 30 |
| Overweight | – | Diagnostic Test: serum Mn, Se, iron, Cu & Zn levelsPatients with BMI 25-30 |
| Control | – | Diagnostic Test: serum Mn, Se, iron, Cu & Zn levelsPatients with BMI less than 25 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Normal,overweight and obese adolescents
Key inclusion criteria (2 listed)
- Patients in adolescent age (12-18 years old)
- Patients with BMI over 25.
Key exclusion criteria (4 listed)
- Patients younger than 12 years old or older than 18 years old.
- Patients with history of chronic use of mineral and /or vitamin supplements .
- Patients with syndromal obesity , endocrine disorder and history of any chronic diseases ,
- Patients under special diets or chronic use of medication .
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 |
|---|---|---|
| serum Mn, Se, iron, Cu & Zn levelsEvaluate the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents. | Diagnostic test | Control, Obese, Overweight |
Primary outcome
concentration of serum Manganese
Time frame: 1 year
Evaluate the concentration of serum Mn levels in obese and overweight adolescents.
Concentration of serum selenium
Time frame: 1 year
Evaluate the concentration of serum Se levels in obese and overweight adolescents.
Concentration of serum Iron
Time frame: 1 year
Evaluate the concentration of serum Iron levels in obese and overweight adolescents.
Concentration of serum copper
Time frame: 1 year
Evaluate the concentration of serum Cu levels in obese and overweight adolescents.
Concentration of serum Zinc
Time frame: 1 year
Evaluate the concentration of serum Zn levels in obese and overweight adolescents.
4 secondary outcomes
BMI and its relation to mineral levels
Time frame: 1 year
Visceral fat and it's relation to mineral levels
Time frame: 1 year
Basal metabolic rate and it's relation to mineral levels
Time frame: 1 year
Body fat percentage and it's relation to mineral level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Bluher M. Obesity: Global epidemiology and pathogenesis. Nat. Rev. Endocrinol. 2019;15:288-298. doi: 10.1038/s41574-019-0176-8. \[PubMed\] \[CrossRef\] \[Google Scholar\]Link provided by the sponsor.
- Liu B., Du Y., Wu Y., Snetselaar L.G., Wallace R.B., Bao W. Trends in obesity and adiposity measures by race or ethnicity among adults in the United States 2011-18: Population based study. BMJ. 2021;372:n365. doi: 10.1136/bmj.n365. \[PMC free article\] \[Link provided by the sponsor.
- Li Y., Schoufour J., Wang D.D., Dhana K., Pan A., Liu X., Song M., Liu G., Shin H.J., Sun Q., et al. Healthy lifestyle and life expectancy free of cancer, cardiovascular disease, and type 2 diabetes: Prospective cohort study. BMJ. 2020;368:l6669. doi:Link provided by the sponsor.
- Despres J.P., Carpentier A.C., Tchernof A., Neeland I.J., Poirier P. Management of Obesity in Cardiovascular Practice: JACC Focus Seminar. J. Am. Coll. Cardiol. 2021;78:513-531. doi: 10.1016/j.jacc.2021.05.035. \[PMC free article\] \[PubMed\] \[CrossRef\] \[GLink provided by the sponsor.
- M. Eggersdorfer, U. Akobundu, R.L. Bailey, J. Shlisky, A.M. Beaudreault, G. Bergeron, R.B. Blancato, J.B. Blumberg, M.W. Bourassa, F. Gomes, G. Jensen, M.A. Johnson, D. Mackay, K. Marshall, S.N. Meydani, K.L. Tucker Hidden hunger: solutions for AmericLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mineral Deficiency, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
concentration of serum Manganese (time frame: 1 year). The study lists 5 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 7 Jun 2024.