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To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks |
|
| Control group | Placebo Comparator | This group will be provided with pectin powder provided as two-gram-dose fo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acacia Senegal extract | Dietary Supplement | Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| hormonal changes | Measure changes from the baseline values regarding LH, FSH, and testosterone level | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imad M Fdl-Elmula, PhD | Alneelain University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banoon center for assisted reproduction and, obstetrics and gynecology | Khartoum | 1113 | Sudan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29558953 | Background | 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. | |
| 25716399 |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| D010368 | Pectins |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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|
| Pectin | Dietary Supplement | Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks |
|
| 12 weeks |
| Body Mass index | Measure decrease from the baseline values regarding BMI | 12 weeks |
| 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. |
| 31316836 | Background | 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. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |