HyperlipidemiasADNCT04564352
Hypolipidemic Effect of Adansonia Digitata
An observational study of Hyperlipidemias, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
Adansonia digitata L. (AD) also known as Baobab is a huge tree that grows in many countries in sub-Saharan Africa. Many studies talking about AD biological activity including hypolipidemic, antioxidant and antimicrobials in animal's but not in human, This study will be undertaken to examine the effect of AD juice… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Adansonia digitata
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2020to 1 Aug 2020
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: The study is association case-control in design and involved Sudanese adult subjects (>18 years old - 60 years) living in Saudi Arabia. The cases were subjects who use AD fruit juice as tradition juice.
Who may be able to join
- Tradition users (drink AD juice)
Who cannot join
- Diabetes, hypertension, or chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypolipidemic, Antioxidant Activity of Adansonia Digitata Juice Consumption
Adansonia digitata L. (AD) also known as Baobab is a huge tree that grows in many countries in sub-Saharan Africa. Many studies talking about AD biological activity including hypolipidemic, antioxidant and antimicrobials in animal's but not in human, This study will be undertaken to examine the effect of AD juice consumption against lipid profiles in traditional users and blood samples will be collected form participant's for investigated of lipid profiles pre and post AD juice drinking and the results will be compared.
- Conditions
- Hyperlipidemias
- Being tested
- Adansonia digitata
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adansonia digitataDietary supplement
Also called Baobab
Juice of AD fruit
| Study group | Role | What they receive |
|---|---|---|
| 2 | Adansonia digitata (Baobab) Receives: Dietary Supplement: Adansonia digitata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease cholesterol level
Hypolipidemias
Measured: 6 month's
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Jan 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Ahmed, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564352
- Sponsor's protocol ID
- CLS 201978
- Other IDs
- Taibah University
- Acronym
- AD
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After participant's allow us to share their data
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypolipidemic, Antioxidant Activity of Adansonia Digitata Juice Consumption
- ClinicalTrials.gov ID
- NCT04564352
- Acronym / sponsor ID
- AD / CLS 201978
- Conditions
- Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 25 Sep 2020 (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.
Adansonia digitata L. (AD) also known as Baobab is a huge tree that grows in many countries in sub-Saharan Africa. Many studies talking about AD biological activity including hypolipidemic, antioxidant and antimicrobials in animal's but not in human, This study will be undertaken to examine the effect of AD juice consumption against lipid profiles in traditional users and blood samples will be collected form participant's for investigated of lipid profiles pre and post AD juice drinking and the results will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Dietary Supplement: Adansonia digitataAdansonia digitata (Baobab) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study is association case-control in design and involved Sudanese adult subjects (>18 years old - 60 years) living in Saudi Arabia. The cases were subjects who use AD fruit juice as tradition juice.
Key inclusion criteria (1 listed)
- Tradition users (drink AD juice)
Key exclusion criteria (1 listed)
- Diabetes, hypertension, or chronic illness
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 |
|---|---|---|
| Adansonia digitataAlso: BaobabJuice of AD fruit | Dietary supplement | 2 |
Primary outcome
Decrease cholesterol level
Time frame: 6 month's
Hypolipidemias
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 25 Sep 2020.
- Individual participant dataSharing planned: Undecided. After participant's allow us to share their data
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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?
An observational study of Hyperlipidemias, run by Taibah 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 1 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: finished, as of the sponsor's last update on 25 Sep 2020. 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?
Decrease cholesterol level (time frame: 6 month's). 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 25 Sep 2020.