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

NCT04215380 — Not applicable, Unknown, 60 participants, Lamis Kaddam
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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

RegistryNCT04215380, acronym GA&PCO
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment60 (Estimated)
SponsorLamis Kaddam (Other)
ConditionsPolycystic Ovary Syndrome
InterventionsAcacia Senegal extract, Pectin (Dietary supplement)
Datesstart 2020-01-25 (estimated), primary completion 2020-04-15 (estimated), completion 2020-06-15 (estimated), first posted 2020-01-02, last updated 2020-01-23
Locations1 site in Sudan

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Intervention GroupExperimentalDietary Supplement: Acacia Senegal extractThis arm will receive 100% natural Gum Arabic provided in a powder form as 30-grams-dose for 12 weeks
Control groupPlacebo comparatorDietary Supplement: PectinThis group will be provided with pectin powder provided as two-gram-dose fo
  • Acacia Senegal extract (Dietary supplement), also known as (Gum Arabic): Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks
  • Pectin (Dietary supplement): Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

+Outcome measures

Primary outcomes

  • hormonal changes [12 weeks]: Measure changes from the baseline values regarding LH, FSH, and testosterone level

Secondary outcomes

  • Metabolic change Serum cholestrol [12 weeks]: Measure decrease from the baseline values regarding serum cholesterol level
  • Metabolic change HBA1C [12 weeks]: Measure decrease from the baseline values regarding HBA1c
  • Body Mass index [12 weeks]: Measure decrease from the baseline values regarding BMI

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

* Diabetic patients
* Menopausal women
* History of allergy to Gum Arabic

+Locations (1)

FacilityCityCountryStatus
Banoon center for assisted reproduction and, obstetrics and gynecologyKhartoumSudan

+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. PMID 29558953
  • 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. PMID 25716399
  • 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. PMID 31316836

+Investigators

My Notes