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Polycystic Ovary SyndromeNCT04163120

Effects of a Ketogenic Diet on PCOS Outcomes

A study testing Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY) in people with Polycystic Ovary Syndrome, run by University of Padova at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteItaly
Study dates
Jan 2017to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between
  • oligo/anovulation
  • hyperandrogenism
  • clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria
  • fertile age (18-45 years);
  • BMI> 25 kg/m2,
  • desire to lose weight;
  • acceptance not to use contraceptives during the experimental period

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Nutrition and Exercise Lab, DSB, University of Padova

    Padova, 35131

Other trials in Italy

About this study

Official title: Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome

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

Read the detailed description

Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.

Being tested
Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04163120
Study groupRoleWhat they receive
InterventionExperimentalIn this single arm study subjects follow a low calorie mediterranean ketogenci diet
Receives: Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight

    Body weight will be measured by an electronic scale

    Measured: 12 weeks

  2. Fat body mass

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

    Measured: 12 weeks

  3. LH

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

    Measured: after 12 weeks

  4. FSH

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

    Measured: 12 weeks

  5. Total testosterone

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

    Measured: 12 weeks

  6. Insulin

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

    Measured: 12 weeks

  7. DHEAS

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

    Measured: 12 weeks

  8. progesterone

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

    Measured: 12 weeks

  9. estradiol

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

    Measured: 12 weeks

  10. SHBG

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

    Measured: 12 weeks

  11. HOMA

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

    Measured: 12 weeks

  12. blood glucose

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

    Measured: 12 weeks

  13. 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.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Ketone bodies

    Ketone bodies will be measured by Precision Xtra® Blood β-Ketone Test Strips and Precision Xtra® (28) (Abbott Laboratories, Illinois 60064-3500, USA)

    Measured: 12 weeks

  2. total cholesterol

    total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

    Measured: 12 weeks

  3. HDL cholesterol

    HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

    Measured: 12 weeks

  4. LDL cholesterol

    LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

    Measured: 12 weeks

  5. Triglycerides

    TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2019
  2. Study startJan 2017
  3. Primary completionMar 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163120
Sponsor's protocol ID
KDPCOS
Status last verified
Nov 2019
First submitted
10 Nov 2019
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22327146

  • 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.

    PubMed 23801097

  • 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.

    PubMed 31311141

  • 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.

    PubMed 16359551

  • 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.

    PubMed 17509728

  • 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.

    PubMed 40168063

  • 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.

    PubMed 32103756

Questions about this trial

What is this clinical trial studying?

A study testing Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY) in people with Polycystic Ovary Syndrome, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163120, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.

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