- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448858
Minerals Status in Relation to Overweight and Obese Adolescent
Effect of Body Composition on Some Blood Minerals Status in Obese and Overweight Adolescent; Cross Sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Governorate
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Assiut, Governorate, Egypt, 71111
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in adolescent age (12-18 years old)
- Patients with BMI over 25.
Exclusion Criteria:
- 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 .
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese
Patients with BMI more than 30
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Evaluate the concentration of serum Mn, Se, iron, Cu & Zn levels in obese and overweight adolescents.
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|
Overweight
Patients with BMI 25-30
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Evaluate the concentration of serum Mn, Se, iron, Cu & Zn levels in obese and overweight adolescents.
|
|
Control
Patients with BMI less than 25
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Evaluate the concentration of serum Mn, Se, iron, Cu & Zn levels in obese and overweight adolescents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concentration of serum Manganese
Time Frame: 1 year
|
Evaluate the concentration of serum Mn levels in obese and overweight adolescents.
|
1 year
|
|
Concentration of serum selenium
Time Frame: 1 year
|
Evaluate the concentration of serum Se levels in obese and overweight adolescents.
|
1 year
|
|
Concentration of serum Iron
Time Frame: 1 year
|
Evaluate the concentration of serum Iron levels in obese and overweight adolescents.
|
1 year
|
|
Concentration of serum copper
Time Frame: 1 year
|
Evaluate the concentration of serum Cu levels in obese and overweight adolescents.
|
1 year
|
|
Concentration of serum Zinc
Time Frame: 1 year
|
Evaluate the concentration of serum Zn levels in obese and overweight adolescents.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI and its relation to mineral levels
Time Frame: 1 year
|
Correlate the BMI with these minerals' concentration.
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1 year
|
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Visceral fat and it's relation to mineral levels
Time Frame: 1 year
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Correlate Visceral fat with these minerals' concentration.
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1 year
|
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Basal metabolic rate and it's relation to mineral levels
Time Frame: 1 year
|
Correlate basal metabolic rate with these minerals' concentration.
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1 year
|
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Body fat percentage and it's relation to mineral level
Time Frame: 1 year
|
Correlate body fat percentage with these minerals' concentration.
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1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- 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]
- 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] [
- 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:
- 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 Americ
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Minerals in Adolescent
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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