ObesityNCT04794309
Outcomes of Circuit Training and Low Carbohydrates Diet in the Young Obese Male in KSA
A study testing Circuit training exercise and Healthy high Fiber diet in people with Obesity, run by Majmaah University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Circuit training exercise and Healthy high Fiber diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Apr 2017to 25 Dec 2020
- 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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Obesity
- Being tested
- Circuit training exercise, Healthy high Fiber diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit training exerciseOther
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.
Healthy high Fiber dietDietary supplement
The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The participants will receive circuit training exercise and dietary intervention. Receives: Other: Circuit training exercise; Dietary Supplement: Healthy high Fiber diet |
| Control group | Active comparator | The participants will be only involved in dietary intervention. Receives: Dietary Supplement: Healthy high Fiber diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Body Weight
Measured in kilograms
Measured: 12 weeks
Height
Measured in meters
Measured: 12 weeks
Body mass index
Measured in kg/m^2
Measured: 12 weeks
Waist circumference
Measured in centimeters
Measured: 12 weeks
Hip circumference
Measured in centimeters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start11 Apr 2017
- Primary completion20 Dec 2020
- Study completion25 Dec 2020
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
- Seventy young males with obesity participated in this study. They were divided randomly into two groups. Group 1 received circuit training with low-carbohydrate (LC) diet intervention and Group 2 was the control group. The study variables such as exercise capacity, body composition, skinfold thickness, percentage of body fat (BF%), and lipid profile were measured at the baseline and at the end of a 12-week intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794309
- Sponsor's protocol ID
- MUREC-Apr.11/COM-2017/15
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Data will be available when the article gets published in a journal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04794309
- Acronym / sponsor ID
- MUREC-Apr.11/COM-2017/15
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 12 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Seventy young males with obesity participated in this study. They were divided randomly into two groups. Group 1 received circuit training with low-carbohydrate (LC) diet intervention and Group 2 was the control group. The study variables such as exercise capacity, body composition, skinfold thickness, percentage of body fat (BF%), and lipid profile were measured at the baseline and at the end of a 12-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Circuit training exercise, Dietary Supplement: Healthy high Fiber dietThe participants will receive circuit training exercise and dietary intervention. |
| Control group | Active comparator | Dietary Supplement: Healthy high Fiber dietThe participants will be only involved in dietary intervention. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Circuit training exercisecircuit 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. | Other | Experimental Group |
| Healthy high Fiber dietThe diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist. | Dietary supplement | Control group, Experimental Group |
Primary outcome
Cardiometabolic index
Time frame: 12 weeks
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.
Exercise capacity
Time frame: 12 weeks
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.
Body Weight
Time frame: 12 weeks
Measured in kilograms
Height
Time frame: 12 weeks
Measured in meters
Body mass index
Time frame: 12 weeks
Measured in kg/m^2
Waist circumference
Time frame: 12 weeks
Measured in centimeters
Hip circumference
Time frame: 12 weeks
Measured in centimeters
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 12 Mar 2021.
- Individual participant dataSharing planned: No. The Data will be available when the article gets published in a journal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit training exercise and Healthy high Fiber diet in people with Obesity, run by Majmaah 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 6 inclusion and 2 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 12 Mar 2021. 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?
Cardiometabolic index (time frame: 12 weeks). The study lists 7 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 12 Mar 2021.