DyslipidemiasNCT04164771
Effect of Aerobic Training and Moringa Oleifera on Dyslipidemia and Cardiac Endurance
A study testing Aerobic training and Moringa Oleifera in people with Dyslipidemias, run by Aga Khan University.
Trial summary
Aerobic training is essential for maintaining and improving physical performance and has a positive effect on physiological functions as well as anthropometric characteristics. It also has positive effect on cardiovascular health and carries a number of beneficial effects on the whole body functions and systems. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Aerobic training and Moringa Oleifera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and no medical conditions.
- LDL level should be 160-189 mg/dl
- HDL level should be < 40 mg/dl
- Tri glyceride level should be 200-499 mg/dl
- Total cholesterol level should be > 200 mg/dl).
- Beep Test score should be less than 10.5 or less than 40% vo2 max
Who cannot join
- Any disease condition as anemia, physical injuries, chronic disease
- Not capable of doing aerobic training
Trial locations and contacts
No sites are listed yet.
About this study
Aerobic training is essential for maintaining and improving physical performance and has a positive effect on physiological functions as well as anthropometric characteristics. It also has positive effect on cardiovascular health and carries a number of beneficial effects on the whole body functions and systems. Aerobic training can also decrease the risk of heart disease in the individual's life.The Moringa leaves are the rich source of minerals, vitamins and other essential phytochemicals. Moringa leave have found to be very effective in many disease particularly diabetic, blood pressure, dyslipidemia and cancer.
Read the detailed description
Aerobic training is an important component for health in daily life as well as sports performance. Aerobic training improves overall health, reduces body fat, maintain body weight, resting blood pressure (systolic and diastolic), maximal oxygen consumption adequate blood supply and provision of oxygen to the body muscles .The studies reveal that aerobic training is valuable for improving cardiovascular health, fitness and quality of life. On account of lack of aerobic engagement around 17 % of the population suffer from heart related ailment, 12 % from diabetes and 10 % from breast cancer. American College of Sports Medicine suggested that 30 minutes of aerobic workout has progressive effects on physical fitness and especially on chronic diseases. Physically fit individuals have got the potential to affectively cope with stress and anxiety and coronary arteries diseases. Aerobic training can raise maximal oxygen uptake, which means body adapts to use oxygen more efficiently during physical activities. Resultantly, the heart becomes efficient and stronger; meaning that the heart doesn't have to work hard to pump blood in resting position. Aerobic training decreases resting heart rate and may increase blood volume and blood plasma. Moringa Oleifera a plant from the family Moringacea, its products are used as a health supplement introduced in Africa and south Asian countries to cure many diseases and improve health status . Moringa leaves are rich source of vitamins and protein. The Moringa oleifera leaves, flowers, seeds and pods are commonly used as vegetables diet in different regions of south Asia. Moringa plant products are sources of vitamin A, b, C and proteins, including the essential amino acids. Moringa Oleifera leaves can be merged in the feed of birds, animals and human which provide wonderful source of protein other than expensive ingredients. The Moringa oil is used in cooking products as well as for lubrication. There are scientific indications that Moringa Oleifera holds therapeutic potential for hyperlipidemia, diabetes and cardiovascular diseases. The use of herbal supplements has increased rapidly during the first decade of the twentieth century. The nutrients of Moringa are considered to be useful for disorders including skin disease, malnutrition and sexual problem.Different experimental studies has described that Moringa oleifera leaves have therapeutic potential for chronic hyperglycemia and dyslipidemia . Moringa Oleifera is used as a hypolipidemic medication to improve the lipid profile of rats fed on atherogenic diet. Moringa Oleifera intake is more effective in prevention than in treatment of hyperlipidemia.It is documented that overuse of Moringa supplements can cause high increase of iron. Hence, a daily 70 g quantity of Moringa is recommended to be batter and preventive for accumulation of nutrients.This research study is due to be conducted to determine the effect of aerobic training and Moringa Oleifera on dyslipidemia and cardiac endurance
- Conditions
- Dyslipidemias
- Being tested
- Aerobic training and Moringa Oleifera
- Keywords
- Aerobic training, Moringa, Cardioprotection
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training and Moringa OleiferaOther
Aerobic exercises/training refers to any type of rhythmic, continuous physical activities that use large group of muscles like walking, running, cycling, and swimming consuming additional amount of energy while Moringa Oleifera a plant from the family Moringacea, its products are used as a health supplement introduced in Africa and south Asian countries to cure many diseases and improve health status
| Study group | Role | What they receive |
|---|---|---|
| Moringa Group | Experimental | Participants will receive 5-7g of moringa diet daily for 6 weeks. Receives: Other: Aerobic training and Moringa Oleifera |
| Aerobic training Group | Experimental | Participants will receive 5-7g of moringa diet daily and will do 30 minutes of aerobic training daily for 6 weeks. Receives: Other: Aerobic training and Moringa Oleifera |
| Moringa and Aerobic training | Experimental | Participants will do 30 minutes of aerobic training daily for 6 weeks Receives: Other: Aerobic training and Moringa Oleifera |
| Control Group (T4) | No intervention | Participants will not recieve any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive effect of aerobic training and Moringa Oleifera on dyslipidemia and cardiac endurance
Change in level of HDL, LDL and triglyceride, impact on cardiac endurance
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 posted15 Nov 2019
- Study startFeb 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Muhammad Safdar Ali
- Responsible party
- Principal investigator, NASEER AHMED, Aga Khan University
- Investigators
- Naseer Ahmed, Ph.D, Principal investigator, Agha Khan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164771
- Sponsor's protocol ID
- NA 125
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2019
- Last updated
- 18 Dec 2019
- 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training and Moringa Oleifera on Dyslipidemia and Cardiac Endurance
- ClinicalTrials.gov ID
- NCT04164771
- Acronym / sponsor ID
- NA 125
- Conditions
- Dyslipidemias
- Keywords
- Aerobic training, Moringa, Cardioprotection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Muhammad Safdar Ali
- Study start
- Feb 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 15 Nov 2019 (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.
Aerobic training is essential for maintaining and improving physical performance and has a positive effect on physiological functions as well as anthropometric characteristics. It also has positive effect on cardiovascular health and carries a number of beneficial effects on the whole body functions and systems. Aerobic training can also decrease the risk of heart disease in the individual's life.The Moringa leaves are the rich source of minerals, vitamins and other essential phytochemicals. Moringa leave have found to be very effective in many disease particularly diabetic, blood pressure, dyslipidemia and cancer.
Detailed description
Aerobic training is an important component for health in daily life as well as sports performance. Aerobic training improves overall health, reduces body fat, maintain body weight, resting blood pressure (systolic and diastolic), maximal oxygen consumption adequate blood supply and provision of oxygen to the body muscles .The studies reveal that aerobic training is valuable for improving cardiovascular health, fitness and quality of life. On account of lack of aerobic engagement around 17 % of the population suffer from heart related ailment, 12 % from diabetes and 10 % from breast cancer. American College of Sports Medicine suggested that 30 minutes of aerobic workout has progressive effects on physical fitness and especially on chronic diseases. Physically fit individuals have got the potential to affectively cope with stress and anxiety and coronary arteries diseases. Aerobic training can raise maximal oxygen uptake, which means body adapts to use oxygen more efficiently during physical activities. Resultantly, the heart becomes efficient and stronger; meaning that the heart doesn't have to work hard to pump blood in resting position. Aerobic training decreases resting heart rate and may increase blood volume and blood plasma. Moringa Oleifera a plant from the family Moringacea, its products are used as a health supplement introduced in Africa and south Asian countries to cure many diseases and improve health status . Moringa leaves are rich source of vitamins and protein. The Moringa oleifera leaves, flowers, seeds and pods are commonly used as vegetables diet in different regions of south Asia. Moringa plant products are sources of vitamin A, b, C and proteins, including the essential amino acids. Moringa Oleifera leaves can be merged in the feed of birds, animals and human which provide wonderful source of protein other than expensive ingredients. The Moringa oil is used in cooking products as well as for lubrication. There are scientific indications that Moringa Oleifera holds therapeutic potential for hyperlipidemia, diabetes and cardiovascular diseases. The use of herbal supplements has increased rapidly during the first decade of the twentieth century. The nutrients of Moringa are considered to be useful for disorders including skin disease, malnutrition and sexual problem.Different experimental studies has described that Moringa oleifera leaves have therapeutic potential for chronic hyperglycemia and dyslipidemia . Moringa Oleifera is used as a hypolipidemic medication to improve the lipid profile of rats fed on atherogenic diet. Moringa Oleifera intake is more effective in prevention than in treatment of hyperlipidemia.It is documented that overuse of Moringa supplements can cause high increase of iron. Hence, a daily 70 g quantity of Moringa is recommended to be batter and preventive for accumulation of nutrients.This research study is due to be conducted to determine the effect of aerobic training and Moringa Oleifera on dyslipidemia and cardiac endurance
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moringa Group | Experimental | Other: Aerobic training and Moringa OleiferaParticipants will receive 5-7g of moringa diet daily for 6 weeks. |
| Aerobic training Group | Experimental | Other: Aerobic training and Moringa OleiferaParticipants will receive 5-7g of moringa diet daily and will do 30 minutes of aerobic training daily for 6 weeks. |
| Moringa and Aerobic training | Experimental | Other: Aerobic training and Moringa OleiferaParticipants will do 30 minutes of aerobic training daily for 6 weeks |
| Control Group (T4) | No intervention | –Participants will not recieve any treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy and no medical conditions.
- LDL level should be 160-189 mg/dl
- HDL level should be < 40 mg/dl
- Tri glyceride level should be 200-499 mg/dl
- Total cholesterol level should be > 200 mg/dl).
Key exclusion criteria (2 listed)
- Any disease condition as anemia, physical injuries, chronic disease
- Not capable of doing aerobic training
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 |
|---|---|---|
| Aerobic training and Moringa OleiferaAerobic exercises/training refers to any type of rhythmic, continuous physical activities that use large group of muscles like walking, running, cycling, and swimming consuming additional amount of energy while Moringa Oleifera a plant from the family Moringacea, its products are used as a health supplement introduced in Africa and south Asian countries to cure many diseases and improve health status | Other | Aerobic training Group, Moringa Group, Moringa and Aerobic training |
Primary outcome
Positive effect of aerobic training and Moringa Oleifera on dyslipidemia and cardiac endurance
Time frame: 6 weeks
Change in level of HDL, LDL and triglyceride, impact on cardiac endurance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Dyslipidemias
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Naseer Ahmed, Ph.D principal investigator
Agha Khan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Moringa Oleifera in people with Dyslipidemias, run by Aga Khan University.
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: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naseer Ahmed, Ph.D (03333382013 ext. 4465, dr.naseer99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive effect of aerobic training and Moringa Oleifera on dyslipidemia and cardiac endurance (time frame: 6 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 18 Dec 2019.