Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.
NCT ID: NCT05952349
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2023-07-01
2024-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome
NCT03117517
Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS
NCT04009603
Probiotic Intervention in PCOS
NCT04593459
Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls
NCT06479434
Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS
NCT05653895
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
L-carnitine is synthesized by the human body as an endogenous compound, it plays a very important role in the metabolism of fatty acid. L-Carnitine is a cofactor and it help in the oxidation of fatty acids by transporting long-chain of fatty acids across mitochondrial membrane. LC levels are found reduced in patients having PCOS; therefore, for the proper management for insulin resistance and obesity in women adjunctive therapy of LC could be beneficial.
Recent studies on olive oil shows that it helps in reducing fatty liver, while olive oil consumption had no effects on the lipid profile. Olive oil has excellent anti-inflammatory potentials against IL-6,IL-8 and TNF produced into the bloodstream as compared to metformin. As a result, it can be used in PCOS treatment.
IL-6 shows an essential part in endocrine system as a major pro-inflammatory cytokine, particularly related to ovarian growth and the course of fertilization and implantation. IL-6 is involved in low grade chronic inflammation in female with PCOS2. IL-6 also showed to have an effect on insulin resistance and cardiovascular abnormalities . Elevated IL-6 levels is reported to be associated with increase weight, a major risk factor for type II diabetes.
IL-8 is proinflammatory cytokine.Il-8 is chemoattractant and it activate neutrophils. Proinflammatory markers like il-6 and il-8 are involved in the development in development of insulin resistance in PCO. Insulin resistance is involved in exaggeration of inflammatory process.
Arginine is amino acid by nature. It is an essential substrate for nitric oxide synthesis which is involved in insulin signaling. Its supplementation can improve metabolic disorders, immune function, wound healing, lean tissue mass, and brown adipose tissue growth.Co-q10 act as a cofactor in the electron transport chain and in the series of redox reaction which are crucial in the synthesis of adenosine tri phosphate. Co-Q10 is essential of the health of almost all organs and tissues because ATP is the soul requirement of all cellular functions. Coq-10 is the most important lipid antioxidants, it guards against the formation of free radicals and their alterations to proteins, lipids, and DNA.
PCOS is an anti-inflammatory condition. Previous studies shows that level of certain cytokines are elevated in individual with PCOS. Studies related to inflammatory markers and PCOS are very few so, this research will help us in better understanding of inflammatory markers and PCOS and it will also help us in deciding a more better treatment plan for female patients having PCOS.The purpose of this study is to determine the effects of metformin and combination of olive oil plus nutritional supplements after 3 months, on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combination Therapy Group
ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD
Standard Therapy Group
ARM # 2 METFORMIN 1000MG (BD)
Metformin (1000 mg Twice a day)
44 Patients with PCOS receiving Metformin 1000mg (BD)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD
Metformin (1000 mg Twice a day)
44 Patients with PCOS receiving Metformin 1000mg (BD)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Hyperandrogenism
2. Polycystic ovaries
3. Menstrual irregularities
* Age 18-34 years
Exclusion Criteria
* Women using other medications simultaneously which may affect hormonal changes
* Previous history of ovarian surgery
* Congenital adrenal hyperplasia
* Thyroid diseases
* Autoimmune diseases
* •
18 Years
34 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Khyber Medical University Peshawar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohsin Shah
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohsin Shah, PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Physiology, Khyber Medical University, Peshawar Pakistan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gynecology and Obstetric, Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ortega-Gonzalez C, Luna S, Hernandez L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A. Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. doi: 10.1210/jc.2004-1965. Epub 2004 Dec 14.
Xu X, Du C, Zheng Q, Peng L, Sun Y. Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93.
Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ. Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1994 May;43(5):647-54. doi: 10.1016/0026-0495(94)90209-7.
Hwang KR, Choi YM, Kim JJ, Chae SJ, Park KE, Jeon HW, Ku SY, Kim SH, Kim JG, Moon SY. Effects of insulin-sensitizing agents and insulin resistance in women with polycystic ovary syndrome. Clin Exp Reprod Med. 2013 Jun;40(2):100-5. doi: 10.5653/cerm.2013.40.2.100. Epub 2013 Jun 30.
Takemura Y, Osuga Y, Yoshino O, Hasegawa A, Hirata T, Hirota Y, Nose E, Morimoto C, Harada M, Koga K, Tajima T, Yano T, Taketani Y. Metformin suppresses interleukin (IL)-1beta-induced IL-8 production, aromatase activation, and proliferation of endometriotic stromal cells. J Clin Endocrinol Metab. 2007 Aug;92(8):3213-8. doi: 10.1210/jc.2006-2486. Epub 2007 May 15.
Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.
Yahay M, Heidari Z, Allameh Z, Amani R. The effects of canola and olive oils consumption compared to sunflower oil, on lipid profile and hepatic steatosis in women with polycystic ovarian syndrome: a randomized controlled trial. Lipids Health Dis. 2021 Jan 29;20(1):7. doi: 10.1186/s12944-021-01433-9.
Peng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S. Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016.
Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.
Wu G, Meininger CJ, McNeal CJ, Bazer FW, Rhoads JM. Role of L-Arginine in Nitric Oxide Synthesis and Health in Humans. Adv Exp Med Biol. 2021;1332:167-187. doi: 10.1007/978-3-030-74180-8_10.
Saini R. Coenzyme Q10: The essential nutrient. J Pharm Bioallied Sci. 2011 Jul;3(3):466-7. doi: 10.4103/0975-7406.84471. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NO:KMU/IBMS/2023/75
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.