NCT04215380

Brief Summary

To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

December 25, 2019

Last Update Submit

January 22, 2020

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • hormonal changes

    Measure changes from the baseline values regarding LH, FSH, and testosterone level

    12 weeks

Secondary Outcomes (3)

  • Metabolic change Serum cholestrol

    12 weeks

  • Metabolic change HBA1C

    12 weeks

  • Body Mass index

    12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks

Dietary Supplement: Acacia Senegal extract

Control group

PLACEBO COMPARATOR

This group will be provided with pectin powder provided as two-gram-dose fo

Dietary Supplement: Pectin

Interventions

Acacia Senegal extractDIETARY_SUPPLEMENT

Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks

Also known as: (Gum Arabic)
Intervention Group
PectinDIETARY_SUPPLEMENT

Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are diagnosed with PCO by independent Gynecologist

You may not qualify if:

  • Diabetic patients
  • Menopausal women
  • History of allergy to Gum Arabic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banoon center for assisted reproduction and, obstetrics and gynecology

Khartoum, 1113, Sudan

Location

Related Publications (3)

  • Babiker R, Elmusharaf K, Keogh MB, Saeed AM. Effect of Gum Arabic (Acacia Senegal) supplementation on visceral adiposity index (VAI) and blood pressure in patients with type 2 diabetes mellitus as indicators of cardiovascular disease (CVD): a randomized and placebo-controlled clinical trial. Lipids Health Dis. 2018 Mar 20;17(1):56. doi: 10.1186/s12944-018-0711-y.

    PMID: 29558953BACKGROUND

  • Esmaeilzadeh S, Andarieh MG, Ghadimi R, Delavar MA. Body mass index and gonadotropin hormones (LH & FSH) associate with clinical symptoms among women with polycystic ovary syndrome. Glob J Health Sci. 2014 Sep 28;7(2):101-6. doi: 10.5539/gjhs.v7n2p101.

    PMID: 25716399BACKGROUND

  • Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Saeed AM. Acacia Senegal (Gum Arabic) Supplementation Modulate Lipid Profile and Ameliorated Dyslipidemia among Sickle Cell Anemia Patients. J Lipids. 2019 Jun 18;2019:3129461. doi: 10.1155/2019/3129461. eCollection 2019.

    PMID: 31316836BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Gum ArabicPectins

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesPlant ExtractsPlant Preparations

Study Officials

  • Imad M Fdl-Elmula, PhD

    Alneelain University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 25, 2019

First Posted

January 2, 2020

Study Start

January 25, 2020

Primary Completion

April 15, 2020

Study Completion

June 15, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, CSR

Locations

SU(1)