Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome (GA&PCO)

Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome: Two Arm Randomized Double Blind Placebo Controlled Study

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

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: Pectin; Dietary supplement: Acacia Senegal extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sudan
  • Khartoum, Sudan, 1113
    • Banoon center for assisted reproduction and, obstetrics and gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks; Other Names: (Gum Arabic)
Placebo Comparator: Control group; This group will be provided with pectin powder provided as two-gram-dose fo	Dietary supplement: Pectin; Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hormonal changes	Measure changes from the baseline values regarding LH, FSH, and testosterone level	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic change Serum cholestrol	Measure decrease from the baseline values regarding serum cholesterol level	12 weeks
Metabolic change HBA1C	Measure decrease from the baseline values regarding HBA1c	12 weeks
Body Mass index	Measure decrease from the baseline values regarding BMI	12 weeks

Collaborators and Investigators

• Sponsor: Lamis Kaddam
• Investigators: Study Director: Imad M Fdl-Elmula, PhD, Alneelain University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Study facility

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2020
• Primary Completion (Anticipated): April 15, 2020
• Study Completion (Anticipated): June 15, 2020

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: GA& PCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No