NCT05066490

Brief 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. Vitamin D was assessed through 25 (OH)D plasma levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

September 22, 2021

Last Update Submit

December 20, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Free fatty acids

    Plasma level of the free fatty acids immediatlly after the exercise.

    After 60 min of training

  • Glycerol

    Plasma level of glycerol immediatlly after the exercise.

    After 60 min of training

  • Vitamin D

    Plasma level of 25 (OH) D immediatlly after the exercise.

    After 60 min of training

Study Arms (2)

endurance exercise

EXPERIMENTAL

This group received endurance exercises only.

Other: Endurance exercise

resistance exersise plus endurance exersise

EXPERIMENTAL

This group received resistance exercises followed by endurance exercises.

Other: Endurance exerciseOther: Resistance exersises.

Interventions

Treadmill training at moderate intensity.

endurance exerciseresistance exersise plus endurance exersise

Resistance exercises using the 10 repetition maximum.

resistance exersise plus endurance exersise

Eligibility Criteria

Age7 Years - 10 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • (OH) D was ranged from 10-20ng/ml

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of applied medical sciences

Ta'if, Mecca Region, 2425, Saudi Arabia

Location

MeSH Terms

Conditions

ObesityVitamin D Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Study Officials

  • Hatem H Allam, Doctoral

    Assisstant professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 4, 2021

Study Start

October 6, 2020

Primary Completion

February 15, 2021

Study Completion

March 25, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations