Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome: Two Arm Randomized Double Blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- hormonal changes
研究概览
简要总结
To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with PCO by independent Gynecologist
排除标准
- •Diabetic patients
- •Menopausal women
- •History of allergy to Gum Arabic
研究组 & 干预措施
Intervention Group
This arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks
干预措施: Acacia Senegal extract (Dietary Supplement)
Control group
This group will be provided with pectin powder provided as two-gram-dose fo
干预措施: Pectin (Dietary Supplement)
结局指标
主要结局
hormonal changes
时间窗: 12 weeks
Measure changes from the baseline values regarding LH, FSH, and testosterone level
次要结局
- Metabolic change HBA1C(12 weeks)
- Body Mass index(12 weeks)
- Metabolic change Serum cholestrol(12 weeks)
研究者
Lamis Kaddam
Director
Al-Neelain University