OverweightNCT04950062
High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
A study testing High Intensity Interval Training and Intermittent Fasting 16/8 Protocol in people with Overweight, run by Horus University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- High Intensity Interval Training and Intermittent Fasting 16/8 Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Jun 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects have to meet all the following criteria in order to participate in the study:
- Overweight subjects with age from 25 to 35 years.
- Body mass index will be range from 25 to 29.9 kg/m2.
- Waist circumference ≥ 80 cm2.
- A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.
Who cannot join
- Subjects with the following disorders will be excluded from participating in this study:
- Musculoskeletal, cardiovascular disorders.
- Asthma, chronic obstructive pulmonary diseases.
- Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
- History of stroke.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Horus University
Damietta, 34518
About this study
Official title: Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects
The purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
Read the detailed description
Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.
Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.
So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.
So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
- Conditions
- Overweight
- Being tested
- High Intensity Interval Training, Intermittent Fasting 16/8 Protocol
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
- Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).
- Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
- Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit.
Intermittent Fasting 16/8 ProtocolOther
Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week. Receives: Other: High Intensity Interval Training |
| Intermittent fasting | Active comparator | Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week. Receives: Other: Intermittent Fasting 16/8 Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in Vo2max
Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
Measured: Baseline and 2 months post-intervention
Assessing the change in body weight
Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
Measured: Baseline and 2 months post-intervention
Assessing the change in waist hip circumference
Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
Measured: Baseline and 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Feb 2021
- Primary completion15 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Elbaz, Horus University
- Investigators
- Manar Elbaz, Demonstrator, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950062
- Sponsor's protocol ID
- Manar_MSc
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects
- ClinicalTrials.gov ID
- NCT04950062
- Acronym / sponsor ID
- Manar_MSc
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Jul 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 purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
Detailed description
Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.
Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.
So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.
So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Other: High Intensity Interval TrainingGroup A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week. |
| Intermittent fasting | Active comparator | Other: Intermittent Fasting 16/8 ProtocolGroup B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects have to meet all the following criteria in order to participate in the study:
Key exclusion criteria (5 listed)
- Subjects with the following disorders will be excluded from participating in this study:
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 |
|---|---|---|
| High Intensity Interval Training1. Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax). 2. Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax. 3. Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit. | Other | High intensity interval training |
| Intermittent Fasting 16/8 ProtocolEvery subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity. | Other | Intermittent fasting |
Primary outcome
Assessing the change in Vo2max
Time frame: Baseline and 2 months post-intervention
Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
Assessing the change in body weight
Time frame: Baseline and 2 months post-intervention
Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
Assessing the change in waist hip circumference
Time frame: Baseline and 2 months post-intervention
Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
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 6 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Manar Elbaz, Demonstrator principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Intermittent Fasting 16/8 Protocol in people with Overweight, run by Horus University at 1 site in Egypt.
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 5 inclusion and 5 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 6 Jul 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 Egypt. 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?
Assessing the change in Vo2max (time frame: Baseline and 2 months post-intervention). 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 6 Jul 2021.