Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome

NCT ID: NCT04215380

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-25

Study Completion Date

2020-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Polycystic ovary syndrome (PCOS) affects 5-20% of women of reproductive age worldwide it increases the risk for type 2 diabetes mellitus, cerebrovascular and cardiovascular events and not to mention it is one of the main causes of infertility. in the management of PCOS life style modification like weight reduction is necessary and recently it was discovered that GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females.so if GA could also affect the hormones and the metabolic changes in PCOs is going to be useful in decreasing the comorbidities and even treating PCOs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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

Group Type EXPERIMENTAL

Acacia Senegal extract

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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

Group Type PLACEBO_COMPARATOR

Pectin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acacia Senegal extract

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

Intervention Type DIETARY_SUPPLEMENT

Pectin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

(Gum Arabic)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria

* Diabetic patients
* Menopausal women
* History of allergy to Gum Arabic
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lamis Kaddam

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamis Kaddam

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Imad M Fdl-Elmula, PhD

Role: STUDY_DIRECTOR

Alneelain University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banoon center for assisted reproduction and, obstetrics and gynecology

Khartoum, , Sudan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sudan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29558953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25716399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31316836 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GA& PCO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gum Acacia and Blood Glucose
NCT03716479 COMPLETED NA