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

• Sponsor: Lamis Kaddam (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04215380
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.7
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: Acacia Senegal extract; Dietary Supplement: Pectin	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jan 25, 2020
• Anticipated Primary Completion Date: Apr 15, 2020
• Anticipated Study Completion Date: Jun 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. hormonal changes [12 weeks]

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

Secondary Outcome Measures

1. Metabolic change Serum cholestrol [12 weeks]

   Measure decrease from the baseline values regarding serum cholesterol level

2. Metabolic change HBA1C [12 weeks]

   Measure decrease from the baseline values regarding HBA1c

3. Body Mass index [12 weeks]

   Measure decrease from the baseline values regarding BMI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

• Diabetic patients

• Menopausal women

• History of allergy to Gum Arabic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banoon center for assisted reproduction and, obstetrics and gynecology	Khartoum		Sudan	1113

Sponsors and Collaborators

• Lamis Kaddam

Investigators

• Study Director: Imad M Fdl-Elmula, PhD, Alneelain University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study facility

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.

• Responsible Party: Lamis Kaddam, Director, Al-Neelain University
• ClinicalTrials.gov Identifier: NCT04215380
• Other Study ID Numbers: GA& PCO
• First Posted: Jan 2, 2020
• Last Update Posted: Jan 23, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome

Study Results

No Results Posted as of Jan 23, 2020