ObesityNCT05066490
Effect of Exercise on Vitamin d in Obese
A study testing Endurance exercise and Resistance exersises. in people with Obesity and Vitamin D Deficiency, run by Taif University at 1 site in Saudi Arabia.
Trial summary
The aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin D status in obese children. Two types of exercises that have different effects on lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. Read more about this study
- Who is it for?
- Ages 7 to 10 years, men only
- Conditions the study is for
- Obesity, Vitamin D Deficiency
- What is being tested?
- Endurance exercise and Resistance exersises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Oct 2020to 25 Mar 2021
- Phase
- Interventional
- 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 7 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Body mass index percentile equal to or greater than the 95th percentile
- All did not receive strength or balance training or involvement in competitive sports emphasizing muscular strength.
- All participants had balance deficiency and mobile flat foot.
- 25(OH) D was ranged from 10-20ng/ml
Who cannot join
- Injury to the lower limb required medical care.
- Deformity of or surgery in the lower limb.
- Visual impairment, or neuromuscular disorders.
- Engagement in obesity treatment programs, three months prior to the study.
- Epileptic fits
- Thyroid medications
- Autoimmune disease
- Take calcium or vitamin d3 supplements, medications for osteoporosis
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of applied medical sciences
Ta'if, Mecca Region, 2425
About this study
Official title: Effect of Exercise-induced Lipolysis on Vitamin D Status in Obese Children
The aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin D status in obese children. Two types of exercises that have different effects on lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. Vitamin D was assessed through 25 (OH)D plasma levels.
Read the detailed description
vitamin D status was monitored through 25 (OH)D levels, and the lipolysis status via the plasma level of the free fatty acids and glycerol immediately after the exercise. All subjects who participated in the study were under supervision for controlling the fat contents and vitamin D in their food for one week prior to the exercise. the subjects fasted eight hours before the exercise. All the exercises were performed between 9 am and 11 am.
- Conditions
- Obesity, Vitamin D Deficiency
- Being tested
- Endurance exercise, Resistance exersises.
- Medical subject headings
- Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseOther
Treadmill training at moderate intensity.
Resistance exersises.Other
Resistance exercises using the 10 repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| endurance exercise | Experimental | This group received endurance exercises only. Receives: Other: Endurance exercise |
| resistance exersise plus endurance exersise | Experimental | This group received resistance exercises followed by endurance exercises. Receives: Other: Endurance exercise; Other: Resistance exersises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free fatty acids
Plasma level of the free fatty acids immediatlly after the exercise.
Measured: After 60 min of training
Glycerol
Plasma level of glycerol immediatlly after the exercise.
Measured: After 60 min of training
Vitamin D
Plasma level of 25 (OH) D immediatlly after the exercise.
Measured: After 60 min of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start6 Oct 2020
- Primary completion15 Feb 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 obese children who suffered from vitamin d deficiency were randomly assigned into three groups. group I (15 children) received endurance exercises and group II (15 children) received endurance exercises preceded by resistance exercises which have a stronger lipolytic effect. group III (10 children) acted as a control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Elsayyad, Taif University
- Investigators
- Hatem H Allam, Doctoral, Study director, Assisstant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066490
- Sponsor's protocol ID
- HAP-02-T-067 428
- Status last verified
- Dec 2021
- First submitted
- 22 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise-induced Lipolysis on Vitamin D Status in Obese Children
- ClinicalTrials.gov ID
- NCT05066490
- Acronym / sponsor ID
- HAP-02-T-067 428
- Conditions
- Obesity, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 4 Oct 2021 (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.
The aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin D status in obese children. Two types of exercises that have different effects on lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. Vitamin D was assessed through 25 (OH)D plasma levels.
Detailed description
vitamin D status was monitored through 25 (OH)D levels, and the lipolysis status via the plasma level of the free fatty acids and glycerol immediately after the exercise. All subjects who participated in the study were under supervision for controlling the fat contents and vitamin D in their food for one week prior to the exercise. the subjects fasted eight hours before the exercise. All the exercises were performed between 9 am and 11 am.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 40 obese children who suffered from vitamin d deficiency were randomly assigned into three groups. group I (15 children) received endurance exercises and group II (15 children) received endurance exercises preceded by resistance exercises which have a stronger lipolytic effect. group III (10 children) acted as a control group.
| Arm | Type | Receives |
|---|---|---|
| endurance exercise | Experimental | Other: Endurance exerciseThis group received endurance exercises only. |
| resistance exersise plus endurance exersise | Experimental | Other: Endurance exercise, Other: Resistance exersises.This group received resistance exercises followed by endurance exercises. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Body mass index percentile equal to or greater than the 95th percentile
- All did not receive strength or balance training or involvement in competitive sports emphasizing muscular strength.
- All participants had balance deficiency and mobile flat foot.
- 25(OH) D was ranged from 10-20ng/ml
Key exclusion criteria (8 listed)
- Injury to the lower limb required medical care.
- Deformity of or surgery in the lower limb.
- Visual impairment, or neuromuscular disorders.
- Engagement in obesity treatment programs, three months prior to the study.
- Epileptic fits
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 |
|---|---|---|
| Endurance exerciseTreadmill training at moderate intensity. | Other | endurance exercise, resistance exersise plus endurance exersise |
| Resistance exersises.Resistance exercises using the 10 repetition maximum. | Other | resistance exersise plus endurance exersise |
Primary outcome
Free fatty acids
Time frame: After 60 min of training
Plasma level of the free fatty acids immediatlly after the exercise.
Glycerol
Time frame: After 60 min of training
Plasma level of glycerol immediatlly after the exercise.
Vitamin D
Time frame: After 60 min of training
Plasma level of 25 (OH) D immediatlly after the exercise.
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 11 Jan 2022.
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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.
Hatem H Allam, Doctoral study director
Assisstant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance exercise and Resistance exersises. in people with Obesity and Vitamin D Deficiency, run by Taif University at 1 site in Saudi Arabia.
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 8 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 11 Jan 2022. 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 Saudi Arabia. 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?
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?
Free fatty acids (time frame: After 60 min of training). The study lists 3 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 11 Jan 2022.