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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215380
Acronym
GA&PCO
Enrollment
60
Registered
2020-01-02
Start date
2020-01-25
Completion date
2020-06-15
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

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.

Interventions

DIETARY_SUPPLEMENTAcacia Senegal extract

Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks

DIETARY_SUPPLEMENTPectin

Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Sponsors

Lamis Kaddam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are diagnosed with PCO by independent Gynecologist

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
hormonal changes12 weeksMeasure changes from the baseline values regarding LH, FSH, and testosterone level

Secondary

MeasureTime frameDescription
Metabolic change Serum cholestrol12 weeksMeasure decrease from the baseline values regarding serum cholesterol level
Metabolic change HBA1C12 weeksMeasure decrease from the baseline values regarding HBA1c
Body Mass index12 weeksMeasure decrease from the baseline values regarding BMI

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026