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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2020

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.

Interventions

  • 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
  • Dietary Supplement: Pectin
    • Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Arms, Groups and Cohorts

  • Experimental: Intervention Group
    • This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks
  • Placebo Comparator: Control group
    • This group will be provided with pectin powder provided as two-gram-dose fo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are diagnosed with PCO by independent Gynecologist Exclusion Criteria:

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lamis Kaddam
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lamis Kaddam, Director – Al-Neelain University
  • Overall Official(s)
    • Imad M Fdl-Elmula, PhD, Study Director, Alneelain University

References

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.

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