Short Term Ketogenic Diet in Polycictic Ovary Syndrome

NCT06469255 | Completed

• 2 other identifiers: KDPCOS2019-14/17
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common health problems in women of reproductive age, characterized by increased androgen levels, impaired ovulatory functions, and polycystic ovaries. In addition to cosmetic problems including hirsutism and acne, it also poses a risk for significant chronic diseases, including infertility, dyslipidemia, obesity, sleep apnea, diabetes, cardiovascular diseases, and various malignancies. The aim of this clinical study was to investigate the effects of short-term low-calorie ketogenic diet (LCKD) intervention on anthropometric, biochemical and hormonal parameters in women with PCOS. The main questions it aims to answer are:

• Is a short-term low-calorie ketogenic diet effective on body composition in overweight women with PCOS?
• Is a short-term low-calorie ketogenic diet effective on biochemical and hormonal parameters in overweight women with PCOS? Participants were diagnosed with PCOS according to the Rotterdam 2003 criteria as a result of the clinical, biochemical and ultrasonographic medical evaluation made by the gynecologist, and those who were found to be eligible for LCKD and volunteered to participate in the study were included in the study. Researchers are examining whether a low-calorie ketogenic diet applied between two menstrual cycles has any effects on anthropometric, biochemical and hormonal parameters in women with PCOS.

Conditions

Polycystic Ovary Syndrome

Keywords

Obesity; Menstrual Dysfunction; Ketogenic Diet

Outcome Measures

Primary Outcomes (5)

• Anthropometric Measurements - Body weight and composition

  Body weight (kg) of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018). Total body weight and body composition analysis (fat ratio, fat, muscle, fluid mass, and phase angle \[PhA\]) were performed following the protocol using the TANİTA MC780 MA bio-electrical impedance device with a sensitivity of 50 grams.

  4 weeks (Between two menstrual cycle)

• Anthropometric Measurements - Height

  Height (cm) measurements of the participants were measured following anthropometric measurement standards with stadiometer (Norton, 2018).

  4 weeks (Between two menstrual cycle)

• Anthropometric Measurements - Circumferences

  Waist, hip, neck, upper middle arm, and chest circumference measurements of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018).

  4 weeks (Between two menstrual cycle)

• Body Mass Index

  Body mass index (BMI) (kg/m2) was calculated using the following equation: body weight (kg)/height (m2) (Misra \& Dhurandhar, 2019).

  4 weeks (Between two menstrual cycle)

• Biochemical Measurements

  This study was conducted between two menstrual cycles to accurately determine baseline and ending basal hormone levels, and biochemical parameters were measured by blood collection on the second to third day of menstruation. On the following days, a nurse extracted blood samples following an 8-12-h fasting. Subsequently, the blood samples were examined for fasting insulin, fasting blood glucose, total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, DHEA-SO4, androstenedione, LH, FSH, estradiol, SHBG, total testosterone, prolactin, IGF-1, and TNF-α levels. HOMA-IR, which was developed by Mathews et al., was used to determine insulin resistance using fasting glucose and insulin levels. It is calculated using the following formula: HOMA-IR = (fasting glucose \[mg/dL\] × fasting insulin \[uIU/mL\])/405 (Matthews et al., 1985).

  4 weeks (Between two menstrual cycle)

Secondary Outcomes (1)

• Food Consumption Evaluation

  1 times before intervention

Study Arms (1)

Ketogenic Diet Intervention

EXPERIMENTAL

4 weeks low calorie Ketogenic Diet intervention

Other: Diet Treatment

Interventions

Diet Treatment OTHER

4 weeks low calorie diet treatment

Ketogenic Diet Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Polycystic ovary syndrome patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female individuals who were diagnosed with PCOS according to the Rotterdam 2003 criteria,
• Individuals suitable for LCKD

You may not qualify if:

• Endocrine disorders other than PCOS,
• Chronic liver disease,
• Chronic kidney disease,
• Hypertension,
• Hyperuricemia,
• Heart failure, infarction or cerebrovascular disease,
• Pregnant and breastfeeding women,
• Severe psychiatric disorders,
• Oncological diseases,
• Individuals using medications that may affect biochemical parameters,
• Individuals with special dietary needs

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

İstanbul Bilgi University

Istanbul, 34060, Turkey (Türkiye)

Location

Related Publications (8)

• Paoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020 Feb 27;18(1):104. doi: 10.1186/s12967-020-02277-0.

  PMID: 32103756 BACKGROUND

• Mavropoulos JC, Yancy WS, Hepburn J, Westman EC. The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Nutr Metab (Lond). 2005 Dec 16;2:35. doi: 10.1186/1743-7075-2-35.

  PMID: 16359551 BACKGROUND

• Barber TM, Franks S. Obesity and polycystic ovary syndrome. Clin Endocrinol (Oxf). 2021 Oct;95(4):531-541. doi: 10.1111/cen.14421. Epub 2021 Jan 31.

  PMID: 33460482 BACKGROUND

• Barrea L, Verde L, Camajani E, Cernea S, Frias-Toral E, Lamabadusuriya D, Ceriani F, Savastano S, Colao A, Muscogiuri G. Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS). Curr Nutr Rep. 2023 Mar;12(1):56-64. doi: 10.1007/s13668-023-00456-1. Epub 2023 Jan 25.

  PMID: 36695999 BACKGROUND

• Cincione RI, Losavio F, Ciolli F, Valenzano A, Cibelli G, Messina G, Polito R. Effects of Mixed of a Ketogenic Diet in Overweight and Obese Women with Polycystic Ovary Syndrome. Int J Environ Res Public Health. 2021 Nov 27;18(23):12490. doi: 10.3390/ijerph182312490.

  PMID: 34886216 BACKGROUND

• Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6.

  PMID: 22153789 BACKGROUND

• Misra A, Dhurandhar NV. Current formula for calculating body mass index is applicable to Asian populations. Nutr Diabetes. 2019 Jan 28;9(1):3. doi: 10.1038/s41387-018-0070-9. No abstract available.

  PMID: 30692514 BACKGROUND

• Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

  PMID: 3899825 BACKGROUND

Related Links

• Norton, K. I. (2018). Standards for anthropometry assessment. In Kinanthropometry and exercise physiology (pp. 68-137). Routledge.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition and Dietetic Department, Clinical Assistant Professor

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: June 21, 2024
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)