Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome (GA&PCO)
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Acacia Senegal extract
Pectin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients who are diagnosed with PCO by independent Gynecologist
Exclusion Criteria:
- Diabetic patients
- Menopausal women
- History of allergy to Gum Arabic
Sites / Locations
- Banoon center for assisted reproduction and, obstetrics and gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control group
Arm Description
This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks
This group will be provided with pectin powder provided as two-gram-dose fo
Outcomes
Primary Outcome Measures
hormonal changes
Measure changes from the baseline values regarding LH, FSH, and testosterone level
Secondary Outcome Measures
Metabolic change Serum cholestrol
Measure decrease from the baseline values regarding serum cholesterol level
Metabolic change HBA1C
Measure decrease from the baseline values regarding HBA1c
Body Mass index
Measure decrease from the baseline values regarding BMI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04215380
Brief Title
Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2020 (Anticipated)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lamis Kaddam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group will be provided with pectin powder provided as two-gram-dose fo
Intervention Type
Dietary Supplement
Intervention Name(s)
Acacia Senegal extract
Other Intervention Name(s)
(Gum Arabic)
Intervention Description
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
Intervention Name(s)
Pectin
Intervention Description
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
Primary Outcome Measure Information:
Title
hormonal changes
Description
Measure changes from the baseline values regarding LH, FSH, and testosterone level
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Metabolic change Serum cholestrol
Description
Measure decrease from the baseline values regarding serum cholesterol level
Time Frame
12 weeks
Title
Metabolic change HBA1C
Description
Measure decrease from the baseline values regarding HBA1c
Time Frame
12 weeks
Title
Body Mass index
Description
Measure decrease from the baseline values regarding BMI
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are diagnosed with PCO by independent Gynecologist
Exclusion Criteria:
Diabetic patients
Menopausal women
History of allergy to Gum Arabic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad M Fdl-Elmula, PhD
Organizational Affiliation
Alneelain University
Official's Role
Study Director
Facility Information:
Facility Name
Banoon center for assisted reproduction and, obstetrics and gynecology
City
Khartoum
ZIP/Postal Code
1113
Country
Sudan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29558953
Citation
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.
Results Reference
background
PubMed Identifier
25716399
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.
Results Reference
background
PubMed Identifier
31316836
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.
Results Reference
background
Links:
URL
http://www.banoonivf.net/index.php/2014-03-24-20-15-27
Description
Study facility
Learn more about this trial
Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome
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