Polycystic Ovary SyndromeNCT04175964
Role of the Ketogenic Diet in Women With PCOS
A study testing ketogenic diet, caloric diet with Metformin and caloric diet in people with Polycystic Ovary Syndrome, run by National Research Centre, Egypt.
Trial summary
For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- ketogenic diet, caloric diet with Metformin and caloric diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Jun 2023
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range between 16-35 years.
- BMI ≥ 27.
- Normal Renal Function.
- Rotterdam criteria for the diagnosis of polycystic ovary syndrome:
- Oligo/anovulation
- Hyperandrogenism
- Polycystic ovaries on ultrasound.
Who cannot join
- Age <16 or >35 years.
- BMI < 27.
- Pregnancy.
- Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia
- Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.
Trial locations and contacts
No sites are listed yet.
About this study
For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrinal abnormalities that affect females within the reproductive age, and are found in about 4% of women. PCOS is commonly associated with symptoms of increased testosterone such as irregular or absent menstrual cycle, increased body hair, and infertility. PCOS is also associated with other disorders such as obesity, insulin resistance, hyperinsulinemia, diabetes mellitus type 2, and dyslipidemia.
Until now, there is no known curative treatment for PCOS. However, anti-diabetic medications can improve many metabolic disorders such as insulin resistance, and increased levels of serum testosterone and total cholesterol. In addition, regulation of diet with exercise could improve the insulin sensitivity. Therefore, managements that aim to decrease the insulin level, improve the insulin resistance and decrease the body weight may be useful for improving symptoms of PCOS.
Ketogenic diets are characterized by a reduction in carbohydrates (usually to less than 50 g/day) and a relative increase in the proportions of protein and fat. People following the keto diet gain 75% of their calories from fat, 20% from protein, and 5% from carbohydrates. Previous studies have revealed that the ketogenic diet of low carbohydrate could decrease the body weight and improve the insulin resistance.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- ketogenic diet, caloric diet with Metformin, caloric diet
- 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.
ketogenic dietBehavioural
The ketogenic diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
caloric diet with MetforminCombination product
The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet with Metformin for 8 weeks.
caloric dietBehavioural
The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | PCO patients that will receive ketogenic diet only Receives: Behavioral: ketogenic diet |
| Group 2 | Experimental | PCO patients that will receive caloric diet with Metformin Receives: Combination Product: caloric diet with Metformin |
| Group 3 | Experimental | PCO patients that will receive caloric diet only Receives: Behavioral: caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.
To evaluate the role of the ketogenic diet in overweight and obese women with PCOS regarding ovulation that will be assessed by serial transvaginal ultrasound.
Measured: 8 weeks
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
Measured: 8 weeks
Secondary outcomes (2)
Role of the ketogenic diet in the affection of testosterone level
To evaluate the role of the ketogenic diet in the affection of testosterone level in overweight and obese women with PCOS
Measured: 8 weeks
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Dec 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazen Abdel Rasheed, National Research Centre, Egypt
- Investigators
- Amr Abbassy, MD, Study director, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175964
- Sponsor's protocol ID
- ketogenic diet in PCOS
- Status last verified
- Oct 2022
- First submitted
- 15 Nov 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 16359551Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
PubMed 18158291Moran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9. doi: 10.1210/jc.2002-020815.
PubMed 12574218
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Ketogenic Diet in Women With PCOS
- ClinicalTrials.gov ID
- NCT04175964
- Acronym / sponsor ID
- ketogenic diet in PCOS
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Nov 2019 (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.
For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrinal abnormalities that affect females within the reproductive age, and are found in about 4% of women. PCOS is commonly associated with symptoms of increased testosterone such as irregular or absent menstrual cycle, increased body hair, and infertility. PCOS is also associated with other disorders such as obesity, insulin resistance, hyperinsulinemia, diabetes mellitus type 2, and dyslipidemia.
Until now, there is no known curative treatment for PCOS. However, anti-diabetic medications can improve many metabolic disorders such as insulin resistance, and increased levels of serum testosterone and total cholesterol. In addition, regulation of diet with exercise could improve the insulin sensitivity. Therefore, managements that aim to decrease the insulin level, improve the insulin resistance and decrease the body weight may be useful for improving symptoms of PCOS.
Ketogenic diets are characterized by a reduction in carbohydrates (usually to less than 50 g/day) and a relative increase in the proportions of protein and fat. People following the keto diet gain 75% of their calories from fat, 20% from protein, and 5% from carbohydrates. Previous studies have revealed that the ketogenic diet of low carbohydrate could decrease the body weight and improve the insulin resistance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: ketogenic dietPCO patients that will receive ketogenic diet only |
| Group 2 | Experimental | Combination Product: caloric diet with MetforminPCO patients that will receive caloric diet with Metformin |
| Group 3 | Experimental | Behavioral: caloric dietPCO patients that will receive caloric diet only |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age range between 16-35 years.
- BMI ≥ 27.
- Normal Renal Function.
- Rotterdam criteria for the diagnosis of polycystic ovary syndrome:
Key exclusion criteria (5 listed)
- Age <16 or >35 years.
- BMI < 27.
- Pregnancy.
- Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia
- Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.
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 |
|---|---|---|
| ketogenic dietThe ketogenic diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks. | Behavioural | Group 1 |
| caloric diet with MetforminThe caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet with Metformin for 8 weeks. | Combination product | Group 2 |
| caloric dietThe caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks. | Behavioural | Group 3 |
Primary outcome
Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.
Time frame: 8 weeks
To evaluate the role of the ketogenic diet in overweight and obese women with PCOS regarding ovulation that will be assessed by serial transvaginal ultrasound.
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
Time frame: 8 weeks
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
2 secondary outcomes
Role of the ketogenic diet in the affection of testosterone level
Time frame: 8 weeks
comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- 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 18158291Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
- Background: PubMed 12574218Moran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9. doi: 10.1210/jc.2002-020815.
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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.
Amr Abbassy, MD study director
National Research Centre, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing ketogenic diet, caloric diet with Metformin and caloric diet in people with Polycystic Ovary Syndrome, run by National Research Centre, Egypt.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mazen Abdel Rasheed, PhD (+201111242366, doctor_mazen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound. (time frame: 8 weeks). 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 NCT04175964, which also lists 3 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 4 Oct 2022.