NCT04564352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 21, 2020

Last Update Submit

September 21, 2020

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

  • Decrease cholesterol level

    Hypolipidemias

    6 month's

Study Arms (1)

2

Adansonia digitata (Baobab)

Dietary Supplement: Adansonia digitata

Interventions

Adansonia digitataDIETARY_SUPPLEMENT

Juice of AD fruit

Also known as: Baobab
2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Tradition users (drink AD juice)

You may not qualify if:

  • Diabetes, hypertension, or chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taibah University

Madinah, 42353, Saudi Arabia

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Clinical chemistry - college of Applied Medical Sciences - Taibah University

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

January 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

SA(1)