- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794309
Outcomes of Circuit Training and Low Carbohydrates Diet in the Young Obese Male in KSA
Effect of Circuit Training With Low-carbohydrate Diet on Body Composition, Cardiometabolic Indices, and Exercise Capacity in Young Males With Mild to Moderate Obesity in Saudi Arabia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Riyadh
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Majmaah, Riyadh, Saudi Arabia, 11952
- Majmaah University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Obese young male subjects with a mass index between BMI >30 kg/m2 and 40 kg/m2).
- Subjects ages range from 20 to 39 years.
- Previously sedentary, defined as no strength training and less than 150 minutes of brisk walking or moderate exercise per week and < less than 60 minutes of vigorous exercise per week in the preceding 6 months.
- Only subjects who are nonsmokers.
- Subjects who are not taking insulin.
- Had no evidence or history of coronary artery disease.
Exclusion Criteria:
- Subjects were excluded if they reported a history of heart disease, respiratory conditions, stroke, diabetes, recent cancer, other life-threatening illness, or any condition that limited their ability to engage in moderate-intensity exercise.
- Smoking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
The participants will receive circuit training exercise and dietary intervention.
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circuit training exercise start with 5 minutes of warming-up then followed by a 30-minute conditioning protocol formed 20 minutes of aerobic exercise and 10 minutes of resisted exercise. The cool-down period is doing in form of walking on a treadmill in low intensity for 5 minutes. Aerobic exercise will be performed on an electronically-braked cycle ergometer (Quinton Excalibur, QuintonInstrument Company, Bothell, WA). resistance exercise (RT) in the form of eight different exercises will be performed during each workout: military press, leg extension, bench press, standing leg curl (ankle weights), lateral pull-down, dumbbell triceps push-down, dumbbell seated biceps curl, and sit-ups (abdominal curls). The participant will do 10 minutes for Aerobic exercise followed by 10 minutes of resistance exercise then 10 minutes for Aerobic exercise. This cycle training will perform five days per week for eight weeks.
The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.
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Active Comparator: Control group
The participants will be only involved in dietary intervention.
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The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiometabolic index
Time Frame: 12 weeks
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High-density lipoprotein, low-density lipoprotein, triglycerides, and total cholesterol will be evaluated through a blood sample from the participants at the start and at the end of 12 weeks of intervention.
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12 weeks
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Exercise capacity
Time Frame: 12 weeks
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The renowned modified sub-maximal treadmill exercise test,which is the leading indicator of EC,was done to calculate maximum oxygen uptake (VO2max).
The test began with a warm-up at a speed of 2.7 km/h for five minutes, andthe speed was increasedevery three minutes until the participantexerted the maximum effort and stopped upon exhaustion.
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12 weeks
|
Body Weight
Time Frame: 12 weeks
|
Measured in kilograms
|
12 weeks
|
Height
Time Frame: 12 weeks
|
Measured in meters
|
12 weeks
|
Body mass index
Time Frame: 12 weeks
|
Measured in kg/m^2
|
12 weeks
|
Waist circumference
Time Frame: 12 weeks
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Measured in centimeters
|
12 weeks
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Hip circumference
Time Frame: 12 weeks
|
Measured in centimeters
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12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- MUREC-Apr.11/COM-2017/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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