UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058151 |
|---|---|
| Receipt number | R000066430 |
| Scientific Title | Effect of Trachyspermum supplementation and jump rope exercise on abdominal obesity and cardiovascular risk factors in 10-15 year-old boys |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/12/19 20:24:45 |
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Basic information
Public title
The combined effect of Trachyspermum supplementation and jump rope exercise on abdominal obesity and cardiovascular risk factors in 10-15 year-old boys
Acronym
Trachyspermum + JUMP rope exercise
Scientific Title
Effect of Trachyspermum supplementation and jump rope exercise on abdominal obesity and cardiovascular risk factors in 10-15 year-old boys
Scientific Title:Acronym
TRAchyspermum + JUMP rope
Region
| Asia(except Japan) |
Condition
Condition
obesity in children
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of Trachyspermum supplementation and jump rope exercise, both individually and in combination, on abdominal obesity and cardiovascular risk factors in boys aged 10 to 15 years. The objective is to determine whether integrating a natural herbal supplement with a structured physical activity program can produce greater improvements in body composition and cardiometabolic health than either intervention alone.
Specifically, the study seeks to assess changes in waist circumference, body mass index (BMI), lipid profile, blood pressure, and fasting blood glucose as primary indicators of abdominal obesity and cardiovascular risk. Additionally, the research will examine the tolerability and safety of Trachyspermum supplementation in a pediatric population and explore whether the combined approach offers a synergistic benefit in promoting health among overweight or at-risk adolescents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
waist/abdominal circumference, weight, and blood tests for LDL, HDL, triglycerides, total cholesterol, and fasting blood sugar
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention lasted eight weeks. The Jump rope training was done 5 days per week for 30 minutes, with progressive intensity, based on Sung Kims protocol. Supplement groups received 3g/day of Trachyspermum powder after breakfast.
Interventions/Control_2
No intervention
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male
Key inclusion criteria
Inclusion and Exclusion Criteria
Initially, participants completed a questionnaire regarding their willingness to participate, personal information, and health status. Criteria for inclusion were:
Interest in participating in the study
No history of cardiovascular diseases
No prior injuries, such as fractures or spinal deviations
No engagement in exercise programs in the past six months or during the study period
Key exclusion criteria
Inclusion and Exclusion Criteria
Initially, participants completed a questionnaire regarding their willingness to participate, personal information, and health status. Criteria for inclusion were:
Interest in participating in the study
No history of cardiovascular diseases
No prior injuries, such as fractures or spinal deviations
No engagement in exercise programs in the past six months or during the study period
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ali |
| Middle name | |
| Last name | Younesian |
Organization
Shahrood University of Technology, Shahrood, Iran
Division name
sport physiology
Zip code
3619995161
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
TEL
+982332392204
ayounesian@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Ali |
| Middle name | |
| Last name | Younesian |
Organization
shahrood university of technology
Division name
sport physiology
Zip code
3619995161
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
TEL
+982332392204
Homepage URL
ayounesian@shahroodut.ac.ir
Sponsor or person
Institute
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
Tel
+982332392204
ayounesian@shahroodut.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://ijdo.ssu.ac.ir/article-1-965-en.html
Publication of results
Published
Result
URL related to results and publications
https://ijdo.ssu.ac.ir/article-1-965-en.html
Number of participants that the trial has enrolled
60
Results
The combination of Trachyspermum and the jump rope exercise significantly improved abdominal
obesity (P< 0.011), LDL (P< 0.005), HDL (P< 0.029), triglycerides (P< 0.005), and fasting blood sugar (P<
0.001), compared to control and exercise-only groups. No significant change was found in total cholesterol (P<
0.343).
Results date posted
| 2025 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Childhood and adolescent overweight can lead to metabolic syndrome in adulthood. This study
aimed to evaluate the effect of Trachyspermum supplement and jump rope exercise on abdominal obesity and
cardiovascular risk factors in obese boys aged 10-15.
Participant flow
In this clinical trial, 60 obese boys with waist circumference above the 90th percentile
were selected using cluster random sampling from schools in Shahroud. The participants were randomly
assigned to four groups: (1) supplement + exercise, (2) exercise only, (3) supplement only, and (4) control.
Adverse events
No adverse events were observed in this study
Outcome measures
The combination of Trachyspermum and jump rope training had beneficial effects on obesity and
cardiovascular risk factors in adolescents, suggesting its use as a non-pharmacological and complementary
treatment for adolescent obesity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066430
