Metabolic SyndromNCT06509464
Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.
A study testing High intensity interval training and Caloric restricted diet in people with Metabolic Syndrom, run by Soma Adel Gaber Abd El-Ghany at 1 site in Egypt.
Trial summary
This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Metabolic Syndrom
- What is being tested?
- High intensity interval training and Caloric restricted diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. 48 Women subjects with age ranges from 25to 45 years.
- 2. Waist height ratio ranges from 49-58 (overweight and seriously overweight).
Who cannot join
- 1. Uncontrolled Diabetes 2. Uncontrolled hypertension 3. Cognitive impaired patients 4. Severe Anemic women 5. Subjects with physical or musculoskeletal disabilities 6. Pregnancy 7. Recent cardiothoracic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy cairo university
Giza, 12611
Hanan Mohamed, BSc, 01151312322 ext. 002, eth.com@pt.cu.edu.eg
About this study
This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.
Read the detailed description
RESPONSE OF METABOLIC SYNDROME SEVERITY SCORE TO HIGH INTENISTY INTERVAL TRAINING IN WOMEN WITH CENTRAL OBESITY
forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups.
Study group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 6 weeks , study group B (n =24) will receive caloric restriction diet
For evaluation Physical efficiency index using Modified Harvard Step test It is a powerful indicator for aerobic fitness. The Fitness Index score is determined according to the following equation
Fitness Index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods).
Metabolic syndrome severity score Metabolic syndrome severity score will be calculated through MetS Calculator (MetSCalc).
-3Laboratory investigation before \& after treatment: for fasting blood glucose level and Lipid profile (total cholesterol, LDL, HDL, TAGs).
4- The 45-item Diet Satisfaction Questionnaire (DSat-45)
- For treatment
1- Grand II Treadmill: (AC999- for maximum weight 150 Kg-
- Conditions
- Metabolic Syndrom
- Being tested
- High intensity interval training, Caloric restricted diet
- Keywords
- Metabolic syndrom severity score, Metabolic syndrom, Central obesity
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingDevice
High intensity interval training on treadmill
Caloric restricted dietDietary supplement
Caloric restricted diet
| Study group | Role | What they receive |
|---|---|---|
| low volume High-intensity interval training (HIIT) | Experimental | group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 3 months, Receives: Device: High intensity interval training; Dietary Supplement: Caloric restricted diet |
| caloric restricted diet. | Experimental | group B (24) will receive caloric restricted diet. Receives: Device: High intensity interval training; Dietary Supplement: Caloric restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome severity score
Measured: 6weeks
Physical efficiency index using Modified Harvard Step test
Measured: 6weeks
The 45-item Diet Satisfaction Questionnaire (DSat-45
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start20 Dec 2024
- Primary completion30 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soma Adel Gaber Abd El-Ghany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soma Adel Gaber Abd El-Ghany, Cairo University
- Investigators
- Nesreen Ghareeb Elnahas, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509464
- Sponsor's protocol ID
- Cairo soma 46
- Status last verified
- Apr 2025
- First submitted
- 9 Jul 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.
- ClinicalTrials.gov ID
- NCT06509464
- Acronym / sponsor ID
- Cairo soma 46
- Conditions
- Metabolic Syndrom
- Keywords
- Metabolic syndrom severity score, Metabolic syndrom, Central obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Soma Adel Gaber Abd El-GhanyUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.
Detailed description
RESPONSE OF METABOLIC SYNDROME SEVERITY SCORE TO HIGH INTENISTY INTERVAL TRAINING IN WOMEN WITH CENTRAL OBESITY
forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups.
Study group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 6 weeks , study group B (n =24) will receive caloric restriction diet
For evaluation Physical efficiency index using Modified Harvard Step test It is a powerful indicator for aerobic fitness. The Fitness Index score is determined according to the following equation
Fitness Index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods).
Metabolic syndrome severity score Metabolic syndrome severity score will be calculated through MetS Calculator (MetSCalc).
-3Laboratory investigation before \& after treatment: for fasting blood glucose level and Lipid profile (total cholesterol, LDL, HDL, TAGs).
4- The 45-item Diet Satisfaction Questionnaire (DSat-45)
- For treatment
1- Grand II Treadmill: (AC999- for maximum weight 150 Kg-
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low volume High-intensity interval training (HIIT) | Experimental | Device: High intensity interval training, Dietary Supplement: Caloric restricted dietgroup A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 3 months, |
| caloric restricted diet. | Experimental | Device: High intensity interval training, Dietary Supplement: Caloric restricted dietgroup B (24) will receive caloric restricted diet. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. 48 Women subjects with age ranges from 25to 45 years.
- 2. Waist height ratio ranges from 49-58 (overweight and seriously overweight).
Key exclusion criteria (1 listed)
- 1. Uncontrolled Diabetes 2. Uncontrolled hypertension 3. Cognitive impaired patients 4. Severe Anemic women 5. Subjects with physical or musculoskeletal disabilities 6. Pregnancy 7. Recent cardiothoracic surgery
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 trainingHigh intensity interval training on treadmill | Device | caloric restricted diet., low volume High-intensity interval training (HIIT) |
| Caloric restricted dietCaloric restricted diet | Dietary supplement | caloric restricted diet., low volume High-intensity interval training (HIIT) |
Primary outcome
Metabolic syndrome severity score
Time frame: 6weeks
Physical efficiency index using Modified Harvard Step test
Time frame: 6weeks
The 45-item Diet Satisfaction Questionnaire (DSat-45
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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.
Nesreen Ghareeb Elnahas, Professor principal investigator
Cairo University
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 Caloric restricted diet in people with Metabolic Syndrom, run by Soma Adel Gaber Abd El-Ghany 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soma Adel Abd El-Ghany, Master degree (0106 196 2553 ext. 002, Somaadelxp123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome severity score (time frame: 6weeks). 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 9 Apr 2025.