PCOSVLCKDNCT04801173
Ketogenic Diet in PCOS With Obesity and Insulin Resistance
A study testing Very low calorie ketogenic diet and Low calorie standard diet in people with PCOS and Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS, Obesity, Insulin Resistance
- What is being tested?
- Very low calorie ketogenic diet and Low calorie standard diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2021to 6 Dec 2021
- 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
- PCOS according to the NIH criteria;
- Body mass index (BMI) between 30 and 35 kg/m3;
- HOMA index ≥ 3 (according to formula: (fasting glucose [mmol/L] × fasting insulin [mIU/L])/22.5)
- Written informed consent.
Who cannot join
- Diabetes type 1
- Exogenous insulin or insulin analogue therapy
- Obesity caused by endocrine disease other than PCOS
- Obesity caused by pharmacotherapy
- Use of a weight-loss diet in the past 3 months
- Use of contraceptive pills in the past 3 months
Show all 22Show fewer
- Severe depression
- Other psychiatric diseases
- Alcohol or psychoactive substance abuse
- Severe hepatic insufficiency
- Renal calculosis
- Renal insufficiency
- Episodes of gout
- Malignant neoplasia
- Previous cardiovascular or cerebrovascular events
- Uncontrolled hypertension
- Water-electrolyte imbalance
- Any pharmacotherapy capable of interfering with glucose metabolism
- Any pharmacotherapy capable of interfering with steroid metabolism
- Menopause
- Pregnancy
- Lactation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Endocrinology and Prevention and Care of Diabetes, S.Orsola Hospital
Bologna, 40138
About this study
Official title: Effect of Very Low Calorie Ketogenic Diet on Obese and Insulin-resistant Women With Polycystic Ovary Syndrome: a Controlled Randomized Trial
The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome
Read the detailed description
Consecutive patients coming to the Endocrinology and Diabetes Clinic of the S.Orsola hospital in Bologna with the suspicion of PCOS, during the study period, will be eligible to participate. In the screening phase, patients from the clinic conforming to the inclusion criteria will be invited to participate in the anovulation screening phase, lasting up to 8 weeks, during which measurements of LH, FSH, estradiol, progesterone and a gynecologic ultrasound will be done on 7th, 14th, 21st and 28th day of the presumed ovulatory cycle, or at any time if amenorrhea present. Consenting participants will provide written informed consent.
Following the anovulation screening, the patients will be randomized in two arms of the study: 1. very low calorie ketogenic diet (VLCKD) and the 2. low calorie standard diet (LCD).
The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the nature of the study intervention.
The group assigned to the VLCKD will follow the VLCKD for 8 weeks, after which they will follow the LCD for the next 8 weeks.
The group assigned to the LCD will follow the LCD for the entire length of the study (16 weeks.)
At the start of the study, after 8 weeks and after 16 weeks, following measurements and tests will be done:
- clinical examination with the measurement of height, body mass, circumference at the waist and hip level, arterial systolic and diastolic pressure, heart rate, Ferriman-Gallwey and videodermoscopic evaluation of hirsutism and bioimpedance body composition measurement;
- blood will be taken for: lipid profile, hepatic transaminases, fasting glucose, fasting insulin, HbA1c, potassium, sodium, urea, calcium, phosphorus, total proteins, albumins, total bilirubin, uric acid, complete blood count, sex hormone binding globulin (SHBG), liquid chromatography-mass spectrometry measurement of testosterone, androstenedione, DHEA, 17OH-progesterone, 17OH-pregnenolone;
- dietary interview;
- psychological evaluation using the following questionnaires: Symptom Questionnaire, the Psychosocial index and the Psychological Well-Being scales.
- Conditions
- PCOS, Obesity, Insulin Resistance
- Being tested
- Very low calorie ketogenic diet, Low calorie standard diet
- Keywords
- Ketogenic diet, Insulin resistance, PCOS, Obesity, Hyperandrogenism
- Medical subject headings
- Obesity, Insulin Resistance, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie ketogenic dietCombination product
Also called Pronokal method
Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method
Low calorie standard dietBehavioural
Low calorie standard diet with no specified dietary supplement addition
| Study group | Role | What they receive |
|---|---|---|
| Very low calorie ketogenic diet | Experimental | Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method Receives: Combination Product: Very low calorie ketogenic diet; Behavioral: Low calorie standard diet |
| Low calorie diet | Active comparator | Control treatment with a low calorie standard diet Receives: Behavioral: Low calorie standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 16 weeks after the start of treatment
Change in body composition measured by bioimpedentiometry
Fat mass and lean mass changes will be considered to estimate change in body composition and reported as %
Measured: 16 weeks after the start of the treatment
Secondary outcomes (6)
Change in Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks after the start of treatment
Change in body composition measured by bioimpedentiometry
Fat mass and lean mass will be considered to estimate change in body composition and reported as %
Measured: 8 weeks after the start of the treatment
Change in Homeostasis Model Assessment Index
Fasting glucose in mmol/L and fasting insulin in mcU/mL will be combined to report Homeostasis Model Assessment Index
Measured: 16 weeks after the start of the treatment
Change in frequency of menstrual cycles
Number of menses in the 16 weeks before will be considered to report the frequency of menstrual cycles
Measured: 16 weeks after the start of the treatment
Change in hirsutism
Modified Ferriman-Gallwey score will be used to measure changes in hirsutism; the minimum and maximum values are 4 and 36 respectively; higher score means a worse outcome
Measured: 16 weeks after the start of the treatment
Change in plasma concentrations of testosterone
testosterone will be reported in ng/mL
Measured: 16 weeks after the start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start2 Mar 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pronokal group
- Responsible party
- Principal investigator, Alessandra Gambineri, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801173
- Sponsor's protocol ID
- VLCKD
- Acronym
- VLCKD
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tosi F, Bonora E, Moghetti P. Insulin resistance in a large cohort of women with polycystic ovary syndrome: a comparison between euglycaemic-hyperinsulinaemic clamp and surrogate indexes. Hum Reprod. 2017 Dec 1;32(12):2515-2521. doi: 10.1093/humrep/dex308.
PubMed 29040529Conway G, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Franks S, Gambineri A, Kelestimur F, Macut D, Micic D, Pasquali R, Pfeifer M, Pignatelli D, Pugeat M, Yildiz BO; ESE PCOS Special Interest Group. The polycystic ovary syndrome: a position statement from the European Society of Endocrinology. Eur J Endocrinol. 2014 Oct;171(4):P1-29. doi: 10.1530/EJE-14-0253. Epub 2014 May 21.
PubMed 24849517Repaci A, Gambineri A, Pasquali R. The role of low-grade inflammation in the polycystic ovary syndrome. Mol Cell Endocrinol. 2011 Mar 15;335(1):30-41. doi: 10.1016/j.mce.2010.08.002. Epub 2010 Aug 11.
PubMed 20708064Barrea L, Marzullo P, Muscogiuri G, Di Somma C, Scacchi M, Orio F, Aimaretti G, Colao A, Savastano S. Source and amount of carbohydrate in the diet and inflammation in women with polycystic ovary syndrome. Nutr Res Rev. 2018 Dec;31(2):291-301. doi: 10.1017/S0954422418000136. Epub 2018 Jul 23.
PubMed 30033891Gonzalez F. Nutrient-Induced Inflammation in Polycystic Ovary Syndrome: Role in the Development of Metabolic Aberration and Ovarian Dysfunction. Semin Reprod Med. 2015 Jul;33(4):276-86. doi: 10.1055/s-0035-1554918. Epub 2015 Jul 1.
PubMed 26132932Volk KM, Pogrebna VV, Roberts JA, Zachry JE, Blythe SN, Toporikova N. High-Fat, High-Sugar Diet Disrupts the Preovulatory Hormone Surge and Induces Cystic Ovaries in Cycling Female Rats. J Endocr Soc. 2017 Nov 2;1(12):1488-1505. doi: 10.1210/js.2017-00305. eCollection 2017 Dec 1.
PubMed 29308444Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
PubMed 30052961Matsuzaki T, Douchi T, Oki T, Ishihara O, Okagaki R, Kajihara T, Tamura M, Kotsuji F, Tajima K, Kawano M, Ishizuka B, Irahara M. Weight reduction using a formula diet recovers menstruation in obese patients with an ovulatory disorder. Reprod Med Biol. 2017 Jul 7;16(3):268-275. doi: 10.1002/rmb2.12034. eCollection 2017 Jul.
PubMed 29259477Mehrabani HH, Salehpour S, Amiri Z, Farahani SJ, Meyer BJ, Tahbaz F. Beneficial effects of a high-protein, low-glycemic-load hypocaloric diet in overweight and obese women with polycystic ovary syndrome: a randomized controlled intervention study. J Am Coll Nutr. 2012 Apr;31(2):117-25. doi: 10.1080/07315724.2012.10720017.
PubMed 22855917Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.
PubMed 25527677Mavropoulos 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 16359551Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
PubMed 31111407Costello MF, Misso ML, Balen A, Boyle J, Devoto L, Garad RM, Hart R, Johnson L, Jordan C, Legro RS, Norman RJ, Mocanu E, Qiao J, Rodgers RJ, Rombauts L, Tassone EC, Thangaratinam S, Vanky E, Teede HJ; International PCOS Network. Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility. Hum Reprod Open. 2019 Jan 4;2019(1):hoy021. doi: 10.1093/hropen/hoy021. eCollection 2019.
PubMed 31486807Moreno B, Bellido D, Sajoux I, Goday A, Saavedra D, Crujeiras AB, Casanueva FF. Comparison of a very low-calorie-ketogenic diet with a standard low-calorie diet in the treatment of obesity. Endocrine. 2014 Dec;47(3):793-805. doi: 10.1007/s12020-014-0192-3. Epub 2014 Mar 4.
PubMed 24584583Goday A, Bellido D, Sajoux I, Crujeiras AB, Burguera B, Garcia-Luna PP, Oleaga A, Moreno B, Casanueva FF. Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Nutr Diabetes. 2016 Sep 19;6(9):e230. doi: 10.1038/nutd.2016.36.
PubMed 27643725
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Very Low Calorie Ketogenic Diet on Obese and Insulin-resistant Women With Polycystic Ovary Syndrome: a Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04801173
- Acronym / sponsor ID
- VLCKD / VLCKD
- Conditions
- PCOS, Obesity, Insulin Resistance
- Keywords
- Ketogenic diet, Insulin resistance, PCOS, Obesity, Hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Pronokal group
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome
Detailed description
Consecutive patients coming to the Endocrinology and Diabetes Clinic of the S.Orsola hospital in Bologna with the suspicion of PCOS, during the study period, will be eligible to participate. In the screening phase, patients from the clinic conforming to the inclusion criteria will be invited to participate in the anovulation screening phase, lasting up to 8 weeks, during which measurements of LH, FSH, estradiol, progesterone and a gynecologic ultrasound will be done on 7th, 14th, 21st and 28th day of the presumed ovulatory cycle, or at any time if amenorrhea present. Consenting participants will provide written informed consent.
Following the anovulation screening, the patients will be randomized in two arms of the study: 1. very low calorie ketogenic diet (VLCKD) and the 2. low calorie standard diet (LCD).
The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the nature of the study intervention.
The group assigned to the VLCKD will follow the VLCKD for 8 weeks, after which they will follow the LCD for the next 8 weeks.
The group assigned to the LCD will follow the LCD for the entire length of the study (16 weeks.)
At the start of the study, after 8 weeks and after 16 weeks, following measurements and tests will be done:
- clinical examination with the measurement of height, body mass, circumference at the waist and hip level, arterial systolic and diastolic pressure, heart rate, Ferriman-Gallwey and videodermoscopic evaluation of hirsutism and bioimpedance body composition measurement;
- blood will be taken for: lipid profile, hepatic transaminases, fasting glucose, fasting insulin, HbA1c, potassium, sodium, urea, calcium, phosphorus, total proteins, albumins, total bilirubin, uric acid, complete blood count, sex hormone binding globulin (SHBG), liquid chromatography-mass spectrometry measurement of testosterone, androstenedione, DHEA, 17OH-progesterone, 17OH-pregnenolone;
- dietary interview;
- psychological evaluation using the following questionnaires: Symptom Questionnaire, the Psychosocial index and the Psychological Well-Being scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low calorie ketogenic diet | Experimental | Combination Product: Very low calorie ketogenic diet, Behavioral: Low calorie standard dietDietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method |
| Low calorie diet | Active comparator | Behavioral: Low calorie standard dietControl treatment with a low calorie standard diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS according to the NIH criteria;
- Body mass index (BMI) between 30 and 35 kg/m3;
- HOMA index ≥ 3 (according to formula: (fasting glucose [mmol/L] × fasting insulin [mIU/L])/22.5)
- Written informed consent.
Key exclusion criteria (22 listed)
- Diabetes type 1
- Exogenous insulin or insulin analogue therapy
- Obesity caused by endocrine disease other than PCOS
- Obesity caused by pharmacotherapy
- Use of a weight-loss diet in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low calorie ketogenic dietAlso: Pronokal methodDietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method | Combination product | Very low calorie ketogenic diet |
| Low calorie standard dietLow calorie standard diet with no specified dietary supplement addition | Behavioural | Low calorie diet, Very low calorie ketogenic diet |
Primary outcome
Change in Body mass index
Time frame: 16 weeks after the start of treatment
Weight and height will be combined to report BMI in kg/m^2
Change in body composition measured by bioimpedentiometry
Time frame: 16 weeks after the start of the treatment
Fat mass and lean mass changes will be considered to estimate change in body composition and reported as %
6 secondary outcomes
Change in Body mass index
Time frame: 8 weeks after the start of treatment
Change in body composition measured by bioimpedentiometry
Time frame: 8 weeks after the start of the treatment
Change in Homeostasis Model Assessment Index
Time frame: 16 weeks after the start of the treatment
Change in frequency of menstrual cycles
Time frame: 16 weeks after the start of the treatment
Change in hirsutism
Time frame: 16 weeks after the start of the treatment
Change in plasma concentrations of testosterone
Time frame: 16 weeks after the start of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Background: PubMed 29040529Tosi F, Bonora E, Moghetti P. Insulin resistance in a large cohort of women with polycystic ovary syndrome: a comparison between euglycaemic-hyperinsulinaemic clamp and surrogate indexes. Hum Reprod. 2017 Dec 1;32(12):2515-2521. doi: 10.1093/humrep/dex308.
- Background: PubMed 24849517Conway G, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Franks S, Gambineri A, Kelestimur F, Macut D, Micic D, Pasquali R, Pfeifer M, Pignatelli D, Pugeat M, Yildiz BO; ESE PCOS Special Interest Group. The polycystic ovary syndrome: a position statement from the European Society of Endocrinology. Eur J Endocrinol. 2014 Oct;171(4):P1-29. doi: 10.1530/EJE-14-0253. Epub 2014 May 21.
- Background: PubMed 20708064Repaci A, Gambineri A, Pasquali R. The role of low-grade inflammation in the polycystic ovary syndrome. Mol Cell Endocrinol. 2011 Mar 15;335(1):30-41. doi: 10.1016/j.mce.2010.08.002. Epub 2010 Aug 11.
- Background: PubMed 30033891Barrea L, Marzullo P, Muscogiuri G, Di Somma C, Scacchi M, Orio F, Aimaretti G, Colao A, Savastano S. Source and amount of carbohydrate in the diet and inflammation in women with polycystic ovary syndrome. Nutr Res Rev. 2018 Dec;31(2):291-301. doi: 10.1017/S0954422418000136. Epub 2018 Jul 23.
- Background: PubMed 26132932Gonzalez F. Nutrient-Induced Inflammation in Polycystic Ovary Syndrome: Role in the Development of Metabolic Aberration and Ovarian Dysfunction. Semin Reprod Med. 2015 Jul;33(4):276-86. doi: 10.1055/s-0035-1554918. Epub 2015 Jul 1.
- Background: PubMed 29308444Volk KM, Pogrebna VV, Roberts JA, Zachry JE, Blythe SN, Toporikova N. High-Fat, High-Sugar Diet Disrupts the Preovulatory Hormone Surge and Induces Cystic Ovaries in Cycling Female Rats. J Endocr Soc. 2017 Nov 2;1(12):1488-1505. doi: 10.1210/js.2017-00305. eCollection 2017 Dec 1.
- Background: PubMed 30052961Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
- Background: PubMed 29259477Matsuzaki T, Douchi T, Oki T, Ishihara O, Okagaki R, Kajihara T, Tamura M, Kotsuji F, Tajima K, Kawano M, Ishizuka B, Irahara M. Weight reduction using a formula diet recovers menstruation in obese patients with an ovulatory disorder. Reprod Med Biol. 2017 Jul 7;16(3):268-275. doi: 10.1002/rmb2.12034. eCollection 2017 Jul.
- Background: PubMed 22855917Mehrabani HH, Salehpour S, Amiri Z, Farahani SJ, Meyer BJ, Tahbaz F. Beneficial effects of a high-protein, low-glycemic-load hypocaloric diet in overweight and obese women with polycystic ovary syndrome: a randomized controlled intervention study. J Am Coll Nutr. 2012 Apr;31(2):117-25. doi: 10.1080/07315724.2012.10720017.
- Background: PubMed 25527677Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.
- Background: PubMed 16359551Mavropoulos 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.
- Background: PubMed 31111407Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie ketogenic diet and Low calorie standard diet in people with PCOS and Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 4 inclusion and 22 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 27 Jan 2022. 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?
Change in Body mass index (time frame: 16 weeks after the start of treatment). The study lists 2 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 NCT04801173, which also lists 15 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 27 Jan 2022.