ClinicalTrials.gg
Status unknownNCT04215380GA&PCOUpdated Jan 23, 2020

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

An interventional study of Acacia Senegal extract and Pectin in Polycystic Ovary Syndrome, sponsored by Lamis Kaddam. Status unknown at 1 site in Sudan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Lamis Kaddam · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Lamis Kaddam is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are diagnosed with PCO by independent Gynecologist

Exclusion criteria

Exclusion Criteria:

  • Diabetic patients
  • Menopausal women
  • History of allergy to Gum Arabic
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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

  • Placebo comparator
    Control group

    This group will be provided with pectin powder provided as two-gram-dose fo

    Dietary Supplement: Pectin

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

    Also known as: (Gum Arabic)

  • Dietary supplementPectin

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

06

What researchers measure

Primary outcomes

  1. hormonal changes

    Measure changes from the baseline values regarding LH, FSH, and testosterone level

    Time frame: 12 weeks

Secondary outcomes

  1. Metabolic change Serum cholestrol

    Measure decrease from the baseline values regarding serum cholesterol level

    Time frame: 12 weeks

  2. Metabolic change HBA1C

    Measure decrease from the baseline values regarding HBA1c

    Time frame: 12 weeks

  3. Body Mass index

    Measure decrease from the baseline values regarding BMI

    Time frame: 12 weeks

07

Study locations

1 site
  • Banoon center for assisted reproduction and, obstetrics and gynecology
    Khartoum, 1113, Sudan
08

References and documents

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. PubMed 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. PubMed 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. PubMed 31316836 ↗

Individual participant data

Plan to share: Yes

Supporting information: Statistical analysis plan, Clinical study report

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04215380
Lead sponsor
Lamis Kaddam
Responsible party
Lamis Kaddam (Director, Al-Neelain University) — Sponsor-investigator
First posted
Jan 2, 2020
Start date
Jan 25, 2020 (estimated)
Primary completion
Apr 15, 2020 (estimated)
Completion
Jun 15, 2020 (estimated)
Last update
Jan 23, 2020

Study contacts

Imad M Fdl-Elmula, PhD
study director · Alneelain University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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