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| Name | Class |
|---|---|
| Abdul Hameed Shoman Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse-based diet | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of androgen hormone | Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms | Change from Baseline sample at 3 months |
| Ovarian volume | An experienced ultrasonographer will evaluate the ovarian volume for each ovary. | Change from Baseline ovarian morphology at 3 months |
| Ovulatory dysfunction | Assessed by measuring the duration of the menstrual cycle | During nine months |
| Lipid profile | Blood Cholesterol will be evaluated for all participants across the 2 study arms | 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 | 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) | Change from Baseline point at 3 months |
| Blood pressure |
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| Measure | Description | Time Frame |
|---|---|---|
| Previous dietary consumption | A validated Arabic food frequency questionnaire will be completed by all participants to evaluate previous dietary consumption of these women and compare it with dietary recommendations. | Baseline point. (At the beginning of the study) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shatha Hammad, PhD | The University of Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Jordan | Amman | Amman Governorate | 11942 | Jordan | ||
| Jordan University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15623819 | Background | 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. | |
| 25194966 | Background | Asemi 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. |
| Label | URL |
|---|---|
| Campos-Vega R, Loarca-Piña G, Oomah BD. Minor components of pulses and their potential impact on human health. Food Research International. 2010;43:461-482 | View source |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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|
| TLC diet | Dietary 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. |
|
In mmHg.(Systolic and Diastolic)
| Change from Baseline Systolic Blood Pressure at 3 months |
| Amman |
| Amman Governorate |
| Jordan |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |