Polycystic Ovarian SyndromeNCT04452968
Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
A study testing intermittent fasting and Caloric restriction in people with Polycystic Ovarian Syndrome and Weight Loss, run by Karachi Medical and Dental College at 1 site in Pakistan.
Trial summary
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Weight Loss, Intermittent Fasting
- What is being tested?
- intermittent fasting and Caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 30 Oct 2020
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS as described by Rotterdam's criteria
Who cannot join
- endocrine disorders
- diabetic
- hypertensive
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- The body weight fluctuated more than 5% in recent 3 months.
- Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
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- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- History of thyroid diseases;
- pregnant
- Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight)
- Patients who cannot be followed for 16 months (due to a health situation or migration)
- Patients who are unwilling or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Fasting and Polycystic Ovarian Syndrome
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.
- Being tested
- intermittent fasting, Caloric restriction
- Medical subject headings
- Polycystic Ovary Syndrome, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fastingBehavioural
Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
Caloric restrictionBehavioural
Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
| Study group | Role | What they receive |
|---|---|---|
| intermittent fasting | Experimental | Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours. Receives: Behavioral: intermittent fasting; Behavioral: Caloric restriction |
| caloric restriction | Active comparator | Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. Receives: Behavioral: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss in kg
Measured: in 3 months
Secondary outcomes (3)
decrease in body fat percentage
Measured: in 3 months
fasting plasma insulin
Measured: in 3 months
blood pressure in mm Hg
Measured: in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karachi Medical and Dental College
- Sponsor type
- University, hospital or other
- Collaborators
- Aziz Medical Center
- Responsible party
- Principal investigator, samia husain, Karachi Medical and Dental College
- Investigators
- Rubina Izhar, Study chair, Aziz Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452968
- Sponsor's protocol ID
- 33
- Status last verified
- Nov 2020
- First submitted
- 26 Jun 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting and Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT04452968
- Acronym / sponsor ID
- 33
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Karachi Medical and Dental CollegeUniversity, hospital or other
- Collaborators
- Aziz Medical Center
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 1 Jul 2020 (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.
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent fasting | Experimental | Behavioral: intermittent fasting, Behavioral: Caloric restrictionDaily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours. |
| caloric restriction | Active comparator | Behavioral: Caloric restrictionDaily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS as described by Rotterdam's criteria
Key exclusion criteria (12 listed)
- endocrine disorders
- diabetic
- hypertensive
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- The body weight fluctuated more than 5% in recent 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 |
|---|---|---|
| intermittent fastingWomen were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours. | Behavioural | intermittent fasting |
| Caloric restrictionDaily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. | Behavioural | caloric restriction, intermittent fasting |
Primary outcome
weight loss in kg
Time frame: in 3 months
3 secondary outcomes
decrease in body fat percentage
Time frame: in 3 months
fasting plasma insulin
Time frame: in 3 months
blood pressure in mm Hg
Time frame: in 3 months
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 25 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Rubina Izhar study chair
Aziz Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent fasting and Caloric restriction in people with Polycystic Ovarian Syndrome and Weight Loss, run by Karachi Medical and Dental College at 1 site in Pakistan.
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 1 inclusion and 12 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 25 Nov 2020. 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 Pakistan. 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?
weight loss in kg (time frame: in 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.