DyslipidemiasNCT04802525
A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise Versus Low-fat Diet, Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
A study testing Moderate-intensity aerobic exercise training in people with Dyslipidemias, run by Cairo University at 1 site in Egypt.
Trial summary
It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Moderate-intensity aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 15 Jan 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age of 30-50 years
- clinical diagnosis with obesity (BMI˃30)
- mild to moderate depression
- impaired blood lipids
- no use of medications last 6-12 months
- no smoking
Who cannot join
- neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
- severe depression
- patients using medications of dyslipidemia, depression, or obesity last 6-12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise is More Effective Than a Low-fat Diet or Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Hence, we assessed the potential influences of a low-fat diet combined with MIAET on blood lipids and depression in those individuals.
- Conditions
- Dyslipidemias
- Being tested
- Moderate-intensity aerobic exercise training
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity aerobic exercise trainingOther
The first group has received Moderate-intensity aerobic exercise training without dietary control, the second group has received a low-fat diet program without exercise intervention, and the third group has received Moderate-intensity aerobic exercise training plus a low-fat diet program for 10 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity aerobic exercise training without dietary control group | Experimental | Not described Receives: Other: Moderate-intensity aerobic exercise training |
| Low-fat diet program without exercise intervention group | Experimental | Not described Receives: Other: Moderate-intensity aerobic exercise training |
| Moderate-intensity aerobic exercise training plus a low-fat diet program group | Experimental | Not described Receives: Other: Moderate-intensity aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
The height and weight were assessed using an electronic digital scale and consequently BMI was calculated
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start10 Oct 2019
- Primary completion2 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802525
- Sponsor's protocol ID
- obesity 2
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise is More Effective Than a Low-fat Diet or Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
- ClinicalTrials.gov ID
- NCT04802525
- Acronym / sponsor ID
- obesity 2
- Conditions
- Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 17 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.
It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Hence, we assessed the potential influences of a low-fat diet combined with MIAET on blood lipids and depression in those individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity aerobic exercise training without dietary control group | Experimental | Other: Moderate-intensity aerobic exercise training |
| Low-fat diet program without exercise intervention group | Experimental | Other: Moderate-intensity aerobic exercise training |
| Moderate-intensity aerobic exercise training plus a low-fat diet program group | Experimental | Other: Moderate-intensity aerobic exercise training |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age of 30-50 years
- clinical diagnosis with obesity (BMI˃30)
- mild to moderate depression
- impaired blood lipids
- no use of medications last 6-12 months
Key exclusion criteria (3 listed)
- neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
- severe depression
- patients using medications of dyslipidemia, depression, or obesity last 6-12 months.
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 |
|---|---|---|
| Moderate-intensity aerobic exercise trainingThe first group has received Moderate-intensity aerobic exercise training without dietary control, the second group has received a low-fat diet program without exercise intervention, and the third group has received Moderate-intensity aerobic exercise training plus a low-fat diet program for 10 consecutive weeks | Other | Low-fat diet program without exercise intervention group, Moderate-intensity aerobic exercise training plus a low-fat diet program group, Moderate-intensity aerobic exercise training without dietary control group |
Primary outcome
Body Mass Index
Time frame: 10 weeks
The height and weight were assessed using an electronic digital scale and consequently BMI was calculated
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 17 Mar 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.
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 Moderate-intensity aerobic exercise training in people with Dyslipidemias, run by Cairo 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 6 inclusion and 3 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 17 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 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?
Body Mass Index (time frame: 10 weeks). 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 17 Mar 2021.