Hypolipidemic Effect of Adansonia Digitata | NCT04564352

Studies
Hypolipidemic Effect of Adansonia Digitata

NCT04564352

Sponsor

Taibah University

Status

Completed

Last Update Posted

Sep 25, 2020Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Hyperlipidemias

Interventions

Adansonia digitata

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Taibah University	Other Identifier	Deanship of scintific research

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Sep 21, 2020

First Submission Date that Met QC Criteria

Sep 21, 2020

First Posted Date

Sep 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2020

Last Update Posted Date

Sep 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed M Ahmed, Associate professor of Clinical chemistry - college of Applied Medical Sciences - Taibah University, Taibah UniversityPrincipal Investigator

Lead Sponsor

Taibah UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		Adansonia digitata (Baobab)	Dietary Supplement: Adansonia digitata

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adansonia digitata	Dietary Supplement	Juice of AD fruit	2	Baobab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease cholesterol level	Hypolipidemias	6 month's

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tradition users (drink AD juice)

Exclusion Criteria:

Diabetes, hypertension, or chronic illness

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taibah University		Madinah		42353	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

After participant's allow us to share their data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided