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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04794309
Other study ID # MUREC-Apr.11/COM-2017/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2017
Est. completion date December 25, 2020

Study information

Verified date March 2021
Source Majmaah University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is one of the common public problems that its prevalence increase incredibly in the last three decades in KSA. Thirty obese males aged 20 to 39 years will participate in the study. The participants will be evaluated on skinfold thickness, percent of body fat, lipid profile, and exercise capacity. All participants will perform a circuit training of aerobic and resistance exercises and be instructed to follow a low carbohydrate diet for eight weeks.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 25, 2020
Est. primary completion date December 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 39 Years
Eligibility Inclusion Criteria: 1. Obese young male subjects with a mass index between BMI >30 kg/m2 and 40 kg/m2). 2. Subjects ages range from 20 to 39 years. 3. 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. 4. Only subjects who are nonsmokers. 5. Subjects who are not taking insulin. 6. Had no evidence or history of coronary artery disease. Exclusion Criteria: 1. 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. 2. Smoking

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Circuit training exercise
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.
Dietary Supplement:
Healthy high Fiber diet
The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.

Locations

Country Name City State
Saudi Arabia Majmaah University Majmaah Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Majmaah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiometabolic index 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. 12 weeks
Primary Exercise capacity 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. 12 weeks
Primary Body Weight Measured in kilograms 12 weeks
Primary Height Measured in meters 12 weeks
Primary Body mass index Measured in kg/m^2 12 weeks
Primary Waist circumference Measured in centimeters 12 weeks
Primary Hip circumference Measured in centimeters 12 weeks
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