Effects of a Ketogenic Diet on PCOS Outcomes

NCT04163120 | Completed DMC

• 1 other identifier: KDPCOS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (13)

• Body Weight

  Body weight will be measured by an electronic scale

  12 weeks

• Fat body mass

  will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA

  12 weeks

• LH

  LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  after 12 weeks

• FSH

  FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• Total testosterone

  Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• Insulin

  Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• DHEAS

  DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• progesterone

  progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• estradiol

  estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• SHBG

  SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• HOMA

  HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5

  12 weeks

• blood glucose

  blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

  12 weeks

• Hirsutism .

  we will use Ferriman Gallwey Score. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.

  12 weeks

Secondary Outcomes (5)

• Ketone bodies

  12 weeks

• total cholesterol

  12 weeks

• HDL cholesterol

  12 weeks

• LDL cholesterol

  12 weeks

• Triglycerides

  12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

In this single arm study subjects follow a low calorie mediterranean ketogenci diet

Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

Interventions

Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY) OTHER

The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis.

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between
• oligo/anovulation
• hyperandrogenism
• fertile age (18-45 years);
• BMI\> 25 kg/m2,
• desire to lose weight;
• acceptance not to use contraceptives during the experimental period

You may not qualify if:

• pregnancy and lactation,
• hormonal therapy and/or insulin-sensitizers in the last 2 months,
• hepatic, renal and heart diseases

Sponsors & Collaborators

• University of Padova: lead
• University of Palermo: collaborator
• Universita di Verona: collaborator
• Vita-Salute San Raffaele University: collaborator

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (7)

• Paoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A. Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11.

  PMID: 22327146 BACKGROUND

• Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26.

  PMID: 23801097 BACKGROUND

• Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.

  PMID: 31311141 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

• Galletly C, Moran L, Noakes M, Clifton P, Tomlinson L, Norman R. Psychological benefits of a high-protein, low-carbohydrate diet in obese women with polycystic ovary syndrome--a pilot study. Appetite. 2007 Nov;49(3):590-3. doi: 10.1016/j.appet.2007.03.222. Epub 2007 Apr 4.

  PMID: 17509728 BACKGROUND

• Moro T, Monaco L, Naro F, Reggiani C, Paoli A. Exercise Intensity and Rest Intervals Effects on Intracellular Signals and Anabolic Response of Skeletal Muscle to Resistance Training. J Strength Cond Res. 2024 Oct 1;38(10):1695-1703. doi: 10.1519/JSC.0000000000004209. Epub 2022 Jan 5.

  PMID: 40168063 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Officials

• Antonio Paoli, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

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: Professor

Model Details: Single arm study

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 14, 2019
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)