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

Polycystic Ovary Syndrome Clinical Trial

— GA&PCO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04215380
• Other study ID #: GA& PCO
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 25, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: January 2020
• Source: Al-Neelain University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

• Diabetic patients

• Menopausal women

• History of allergy to Gum Arabic

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Sudan	Banoon center for assisted reproduction and, obstetrics and gynecology	Khartoum

Sponsors (1)

Lead Sponsor	Collaborator
Lamis Kaddam

Country where clinical trial is conducted

Sudan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hormonal changes	Measure changes from the baseline values regarding LH, FSH, and testosterone level	12 weeks
Secondary	Metabolic change Serum cholestrol	Measure decrease from the baseline values regarding serum cholesterol level	12 weeks
Secondary	Metabolic change HBA1C	Measure decrease from the baseline values regarding HBA1c	12 weeks
Secondary	Body Mass index	Measure decrease from the baseline values regarding BMI	12 weeks

External Links

•   Study facility