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

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

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Acacia Senegal extract
* Dietary Supplement: Pectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed with PCO by independent Gynecologist Exclusion Criteria: Diabetic patients Menopausal women History of allergy to Gum Arabic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |