Polycystic Ovary SyndromeNCT05428566
A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS
A study testing Pulse-based diet and TLC diet in people with Polycystic Ovary Syndrome and Metabolic Syndrome, run by University of Jordan at 2 sites in Jordan.
Trial summary
The main objective of the study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the efficacy of a pulse-based diet (i.e. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Metabolic Syndrome
- What is being tested?
- Pulse-based diet and TLC diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Jan 2022to 30 Oct 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- Aged 18-35 years
Who cannot join
- Individuals that are Keto diet, vegetarian, pregnant, lactating, class 2 obese (body mass index (BMI) ≥35) current smoker, or if they have diabetes, cardiovascular, kidney, liver, or hormonal disease.
- Individuals taking any medication or supplementation known to affect lipid, glucose, or hormone levels, and/or body weight for at least the last 3 months.
- Any individual who has an allergy or intolerance to pulses.
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
The University of Jordan
Amman, Amman Governorate, 11942
Jordan University Hospital
Amman, Amman Governorate
About this study
Official title: A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
The main objective of the study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the efficacy of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, and beans) on the clinical features, biochemical, and hormonal parameters of PCOS compared to the healthy therapeutic lifestyle changes diet.
Read the detailed description
The main objective of the study is to identify the effect of pulses on a range of PCOS and metabolic syndrome features. In this parallel clinical trial, 110 (18-35 years old) women with PCOS will be recruited. Participants will be randomly assigned to either a pulse-based diet or a therapeutic lifestyle changes-based diet. The effect of a pulse-based diet on a range of reproductive and metabolic parameters will be evaluated. The results of this study are anticipated to evaluate the therapeutic merits of a pulse-based diet for women with PCOS which would influence dietary guidelines.
- Conditions
- Polycystic Ovary Syndrome, Metabolic Syndrome
- Being tested
- Pulse-based diet, TLC diet
- Keywords
- Polycystic Ovary Syndrome, Metabolic Syndrome, Therapeutic Lifestyle Changes Diet, Pulse-Based Diet, Aerobic Exercise
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse-based dietDietary supplement
An isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein.
The pulse diet will include two pulse-based meals; each pulse meal will be consisted of about one cup of non-oil seed pulses, different varieties of pulses (dried beans, peas, lentils, lupine and chickpeas) will be used.
TLC dietDietary supplement
An isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein.
The healthy TLC diet will be tailored for each participant according to their energy levels in order to achieve the following amount of nutrients: less than 7% of total calories of saturated fatty acids, up to 10% of total calories of polyunsaturated fat, up to 20% of total calories of monounsaturated fat, less than 200 mg a day of cholesterol, at least 5 to 10 grams a day of soluble fiber.
| Study group | Role | What they receive |
|---|---|---|
| Pulse-based diet | Experimental | The pulse diet will include two pulse-based meals; each pulse meal will be consisted of about one cup of non-oil seed pulses, different varieties of pulses (dried beans, peas, lentils, lupine, and chickpeas) will be used. Varieties of pulses will be included and the participants will be provided with recipes and preparation ideas, which would enhance the palatability of pulses, give different taste choices, and ease the follow of the prescribed diet and encourage the participants to consume it for the target duration.
The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. Receives: Dietary Supplement: Pulse-based diet |
| TLC diet | Placebo comparator | TLC group will be provided with instructions to follow the TLC guidelines and a sample diet plan will be individualized for each participant. The healthy TLC diet will be tailored for each participant according to their energy levels in order to achieve the following amount of nutrients: less than 7% of total calories of saturated fatty acids, up to 10% of total calories of polyunsaturated fat, up to 20% of total calories of monounsaturated fat, less than 200 mg a day of cholesterol, at least 5 to 10 grams a day of soluble fiber.
The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. Receives: Dietary Supplement: TLC diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of androgen hormone
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Measured: Change from Baseline sample at 3 months
Ovarian volume
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Measured: Change from Baseline ovarian morphology at 3 months
Ovulatory dysfunction
Assessed by measuring the duration of the menstrual cycle
Measured: During nine months
Lipid profile
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Measured: Change from Baseline sample at 3 months
Change in fat mass
Body composition scan using InBody 120 (the body composition analyzer) will be evaluated for all participants across the 2 study arms
Measured: Change from Baseline measurements at 3 months
Physical activity
The validated Arabic short form of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate physical activity of all participants. And an overall total physical activity MET-minutes/week score can be computed as: Total physical activity MET-minutes/week = sum of Total (Walking + Moderate + Vigorous) MET- minutes/week scores.
( < 4 : Low), (4-6 Moderate) and ( >6: Vigorous)
Measured: Change from Baseline point at 3 months
Blood pressure
In mmHg.(Systolic and Diastolic)
Measured: Change from Baseline Systolic Blood Pressure at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Abdul Hameed Shoman Foundation
- Responsible party
- Principal investigator, Shatha Hammad, Assistant Professor, University of Jordan
- Investigators
- Shatha Hammad, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428566
- Sponsor's protocol ID
- 2020-2019/27
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apridonidze T, Essah PA, Iuorno MJ, Nestler JE. Prevalence and characteristics of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Apr;90(4):1929-35. doi: 10.1210/jc.2004-1045. Epub 2004 Dec 28.
PubMed 15623819Asemi Z, Samimi M, Tabassi Z, Shakeri H, Sabihi SS, Esmaillzadeh A. Effects of DASH diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome: a randomized clinical trial. Nutrition. 2014 Nov-Dec;30(11-12):1287-93. doi: 10.1016/j.nut.2014.03.008. Epub 2014 Mar 15.
PubMed 25194966Azziz R, Marin C, Hoq L, Badamgarav E, Song P. Health care-related economic burden of the polycystic ovary syndrome during the reproductive life span. J Clin Endocrinol Metab. 2005 Aug;90(8):4650-8. doi: 10.1210/jc.2005-0628. Epub 2005 Jun 8.
PubMed 15944216Baillargeon JP, Carpentier A. Role of insulin in the hyperandrogenemia of lean women with polycystic ovary syndrome and normal insulin sensitivity. Fertil Steril. 2007 Oct;88(4):886-93. doi: 10.1016/j.fertnstert.2006.12.055. Epub 2007 Jun 7.
PubMed 17559844Balen AH, Laven JS, Tan SL, Dewailly D. Ultrasound assessment of the polycystic ovary: international consensus definitions. Hum Reprod Update. 2003 Nov-Dec;9(6):505-14. doi: 10.1093/humupd/dmg044.
PubMed 14714587Barr S, Reeves S, Sharp K, Jeanes YM. An isocaloric low glycemic index diet improves insulin sensitivity in women with polycystic ovary syndrome. J Acad Nutr Diet. 2013 Nov;113(11):1523-1531. doi: 10.1016/j.jand.2013.06.347. Epub 2013 Aug 30.
PubMed 23999280Bhathena RK. Insulin resistance and the long-term consequences of polycystic ovary syndrome. J Obstet Gynaecol. 2011;31(2):105-10. doi: 10.3109/01443615.2010.539722.
PubMed 21281021Carmina E, Napoli N, Longo RA, Rini GB, Lobo RA. Metabolic syndrome in polycystic ovary syndrome (PCOS): lower prevalence in southern Italy than in the USA and the influence of criteria for the diagnosis of PCOS. Eur J Endocrinol. 2006 Jan;154(1):141-5. doi: 10.1530/eje.1.02058.
PubMed 16382003Chavarro JE, Rich-Edwards JW, Rosner BA, Willett WC. A prospective study of dietary carbohydrate quantity and quality in relation to risk of ovulatory infertility. Eur J Clin Nutr. 2009 Jan;63(1):78-86. doi: 10.1038/sj.ejcn.1602904. Epub 2007 Sep 19.
PubMed 17882137Corbould A. Effects of androgens on insulin action in women: is androgen excess a component of female metabolic syndrome? Diabetes Metab Res Rev. 2008 Oct;24(7):520-32. doi: 10.1002/dmrr.872.
PubMed 18615851den Besten G, van Eunen K, Groen AK, Venema K, Reijngoud DJ, Bakker BM. The role of short-chain fatty acids in the interplay between diet, gut microbiota, and host energy metabolism. J Lipid Res. 2013 Sep;54(9):2325-40. doi: 10.1194/jlr.R036012. Epub 2013 Jul 2.
PubMed 23821742Diamanti-Kandarakis E, Argyrakopoulou G, Economou F, Kandaraki E, Koutsilieris M. Defects in insulin signaling pathways in ovarian steroidogenesis and other tissues in polycystic ovary syndrome (PCOS). J Steroid Biochem Mol Biol. 2008 Apr;109(3-5):242-6. doi: 10.1016/j.jsbmb.2008.03.014. Epub 2008 Mar 12.
PubMed 18440223Douglas CC, Gower BA, Darnell BE, Ovalle F, Oster RA, Azziz R. Role of diet in the treatment of polycystic ovary syndrome. Fertil Steril. 2006 Mar;85(3):679-88. doi: 10.1016/j.fertnstert.2005.08.045.
PubMed 16500338Goss AM, Chandler-Laney PC, Ovalle F, Goree LL, Azziz R, Desmond RA, Wright Bates G, Gower BA. Effects of a eucaloric reduced-carbohydrate diet on body composition and fat distribution in women with PCOS. Metabolism. 2014 Oct;63(10):1257-64. doi: 10.1016/j.metabol.2014.07.007. Epub 2014 Jul 18.
PubMed 25125349Gower BA, Chandler-Laney PC, Ovalle F, Goree LL, Azziz R, Desmond RA, Granger WM, Goss AM, Bates GW. Favourable metabolic effects of a eucaloric lower-carbohydrate diet in women with PCOS. Clin Endocrinol (Oxf). 2013 Oct;79(4):550-7. doi: 10.1111/cen.12175. Epub 2013 May 20.
PubMed 23444983
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05428566
- Acronym / sponsor ID
- 2020-2019/27
- Conditions
- Polycystic Ovary Syndrome, Metabolic Syndrome
- Keywords
- Polycystic Ovary Syndrome, Metabolic Syndrome, Therapeutic Lifestyle Changes Diet, Pulse-Based Diet, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Abdul Hameed Shoman Foundation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 23 Jun 2022 (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 main objective of the study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the efficacy of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, and beans) on the clinical features, biochemical, and hormonal parameters of PCOS compared to the healthy therapeutic lifestyle changes diet.
Detailed description
The main objective of the study is to identify the effect of pulses on a range of PCOS and metabolic syndrome features. In this parallel clinical trial, 110 (18-35 years old) women with PCOS will be recruited. Participants will be randomly assigned to either a pulse-based diet or a therapeutic lifestyle changes-based diet. The effect of a pulse-based diet on a range of reproductive and metabolic parameters will be evaluated. The results of this study are anticipated to evaluate the therapeutic merits of a pulse-based diet for women with PCOS which would influence dietary guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulse-based diet | Experimental | Dietary Supplement: Pulse-based dietThe pulse diet will include two pulse-based meals; each pulse meal will be consisted of about one cup of non-oil seed pulses, different varieties of pulses (dried beans, peas, lentils, lupine, and chickpeas) will be used. Varieties of pulses will be included and the participants will be provided with recipes and preparation ideas, which would enhance the palatability of pulses, give different taste choices, and ease the follow of the prescribed diet and encourage the participants to consume it for the target duration. The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. |
| TLC diet | Placebo comparator | Dietary Supplement: TLC dietTLC group will be provided with instructions to follow the TLC guidelines and a sample diet plan will be individualized for each participant. The healthy TLC diet will be tailored for each participant according to their energy levels in order to achieve the following amount of nutrients: less than 7% of total calories of saturated fatty acids, up to 10% of total calories of polyunsaturated fat, up to 20% of total calories of monounsaturated fat, less than 200 mg a day of cholesterol, at least 5 to 10 grams a day of soluble fiber. The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- Aged 18-35 years
Key exclusion criteria (3 listed)
- Individuals that are Keto diet, vegetarian, pregnant, lactating, class 2 obese (body mass index (BMI) ≥35) current smoker, or if they have diabetes, cardiovascular, kidney, liver, or hormonal disease.
- Individuals taking any medication or supplementation known to affect lipid, glucose, or hormone levels, and/or body weight for at least the last 3 months.
- Any individual who has an allergy or intolerance to pulses.
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 |
|---|---|---|
| Pulse-based dietAn isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. The pulse diet will include two pulse-based meals; each pulse meal will be consisted of about one cup of non-oil seed pulses, different varieties of pulses (dried beans, peas, lentils, lupine and chickpeas) will be used. | Dietary supplement | Pulse-based diet |
| TLC dietAn isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. The healthy TLC diet will be tailored for each participant according to their energy levels in order to achieve the following amount of nutrients: less than 7% of total calories of saturated fatty acids, up to 10% of total calories of polyunsaturated fat, up to 20% of total calories of monounsaturated fat, less than 200 mg a day of cholesterol, at least 5 to 10 grams a day of soluble fiber. | Dietary supplement | TLC diet |
Primary outcome
Blood concentration of androgen hormone
Time frame: Change from Baseline sample at 3 months
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Ovarian volume
Time frame: Change from Baseline ovarian morphology at 3 months
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Ovulatory dysfunction
Time frame: During nine months
Assessed by measuring the duration of the menstrual cycle
Lipid profile
Time frame: Change from Baseline sample at 3 months
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Change in fat mass
Time frame: Change from Baseline measurements at 3 months
Body composition scan using InBody 120 (the body composition analyzer) will be evaluated for all participants across the 2 study arms
Physical activity
Time frame: Change from Baseline point at 3 months
The validated Arabic short form of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate physical activity of all participants. And an overall total physical activity MET-minutes/week score can be computed as: Total physical activity MET-minutes/week = sum of Total (Walking + Moderate + Vigorous) MET- minutes/week scores. ( < 4 : Low), (4-6 Moderate) and ( >6: Vigorous)
Blood pressure
Time frame: Change from Baseline Systolic Blood Pressure at 3 months
In mmHg.(Systolic and Diastolic)
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 1 Nov 2024.
- Background: PubMed 15623819Apridonidze T, Essah PA, Iuorno MJ, Nestler JE. Prevalence and characteristics of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Apr;90(4):1929-35. doi: 10.1210/jc.2004-1045. Epub 2004 Dec 28.
- Background: PubMed 25194966Asemi Z, Samimi M, Tabassi Z, Shakeri H, Sabihi SS, Esmaillzadeh A. Effects of DASH diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome: a randomized clinical trial. Nutrition. 2014 Nov-Dec;30(11-12):1287-93. doi: 10.1016/j.nut.2014.03.008. Epub 2014 Mar 15.
- Background: PubMed 15944216Azziz R, Marin C, Hoq L, Badamgarav E, Song P. Health care-related economic burden of the polycystic ovary syndrome during the reproductive life span. J Clin Endocrinol Metab. 2005 Aug;90(8):4650-8. doi: 10.1210/jc.2005-0628. Epub 2005 Jun 8.
- Background: PubMed 17559844Baillargeon JP, Carpentier A. Role of insulin in the hyperandrogenemia of lean women with polycystic ovary syndrome and normal insulin sensitivity. Fertil Steril. 2007 Oct;88(4):886-93. doi: 10.1016/j.fertnstert.2006.12.055. Epub 2007 Jun 7.
- Background: PubMed 14714587Balen AH, Laven JS, Tan SL, Dewailly D. Ultrasound assessment of the polycystic ovary: international consensus definitions. Hum Reprod Update. 2003 Nov-Dec;9(6):505-14. doi: 10.1093/humupd/dmg044.
- Background: PubMed 23999280Barr S, Reeves S, Sharp K, Jeanes YM. An isocaloric low glycemic index diet improves insulin sensitivity in women with polycystic ovary syndrome. J Acad Nutr Diet. 2013 Nov;113(11):1523-1531. doi: 10.1016/j.jand.2013.06.347. Epub 2013 Aug 30.
- Background: PubMed 21281021Bhathena RK. Insulin resistance and the long-term consequences of polycystic ovary syndrome. J Obstet Gynaecol. 2011;31(2):105-10. doi: 10.3109/01443615.2010.539722.
- Background: PubMed 16382003Carmina E, Napoli N, Longo RA, Rini GB, Lobo RA. Metabolic syndrome in polycystic ovary syndrome (PCOS): lower prevalence in southern Italy than in the USA and the influence of criteria for the diagnosis of PCOS. Eur J Endocrinol. 2006 Jan;154(1):141-5. doi: 10.1530/eje.1.02058.
- Background: PubMed 17882137Chavarro JE, Rich-Edwards JW, Rosner BA, Willett WC. A prospective study of dietary carbohydrate quantity and quality in relation to risk of ovulatory infertility. Eur J Clin Nutr. 2009 Jan;63(1):78-86. doi: 10.1038/sj.ejcn.1602904. Epub 2007 Sep 19.
- Background: PubMed 18615851Corbould A. Effects of androgens on insulin action in women: is androgen excess a component of female metabolic syndrome? Diabetes Metab Res Rev. 2008 Oct;24(7):520-32. doi: 10.1002/dmrr.872.
- Background: PubMed 23821742den Besten G, van Eunen K, Groen AK, Venema K, Reijngoud DJ, Bakker BM. The role of short-chain fatty acids in the interplay between diet, gut microbiota, and host energy metabolism. J Lipid Res. 2013 Sep;54(9):2325-40. doi: 10.1194/jlr.R036012. Epub 2013 Jul 2.
- Background: PubMed 18440223Diamanti-Kandarakis E, Argyrakopoulou G, Economou F, Kandaraki E, Koutsilieris M. Defects in insulin signaling pathways in ovarian steroidogenesis and other tissues in polycystic ovary syndrome (PCOS). J Steroid Biochem Mol Biol. 2008 Apr;109(3-5):242-6. doi: 10.1016/j.jsbmb.2008.03.014. Epub 2008 Mar 12.
- Campos-Vega R, Loarca-Piña G, Oomah BD. Minor components of pulses and their potential impact on human health. Food Research International. 2010;43:461-482Link provided by the sponsor.
- 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.
Shatha Hammad, PhD principal investigator
University of Jordan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse-based diet and TLC diet in people with Polycystic Ovary Syndrome and Metabolic Syndrome, run by University of Jordan at 2 sites in Jordan.
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 3 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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. Some participants in this study may receive a placebo. 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?
Blood concentration of androgen hormone (time frame: Change from Baseline sample at 3 months). The study lists 7 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 NCT05428566, which also lists 35 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 1 Nov 2024.