Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Polycystic Ovary Syndrome

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

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 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.

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.

Pulse-based diet

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.

TLC diet

Shatha Hammad, PhD

Shatha Abu-AlNadi

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.

A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women With PCOS

A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women With Polycystic Ovary Syndrome

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.

Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms

An experienced ultrasonographer will evaluate the ovarian volume for each ovary.

Assessed by measuring the duration of the menstrual cycle

Blood Cholesterol will be evaluated for all participants across the 2 study arms

Body composition scan using InBody 120 (the body composition analyzer) will be evaluated for all participants across the 2 study arms

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)

Abdul Hameed Shoman Foundation

University of Jordan

Assistant Professor

Infertility

The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.

Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses.

Gordon A Zello, PhD

Philip Chilibeck, PhD

The purpose of our study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic exercise for improving PCOS disease features and risk factors for metabolic syndrome. We would like to determine the therapeutic effects of a lifestyle program that combines a pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic syndrome.

To date, we have developed the pulse-based and meat-based healthy meals following Therapeutic Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We have been recruiting and enrolling participants into the study with our few set of participants having completed the 4 month intervention. Baseline data have been also collected on all participants assessed for PCOS. Preliminary measurements on POCS characteristics, baseline dietary and exercise habits of women with PCOS will be soon available.

This study involves an intervention comparing a diet containing pulses (i.e. beans, peas, chick peas, lentils) to a diet recommended by the National Cholesterol Education Program (NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women in the pulse-diet group have completed the intervention, nine women in the group receiving the NCEP diet have completed the intervention, four women are currently enrolled on the pulse diet and two women are currently enrolled on the NCEP diet.

Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise

A Lifestyle Intervention for Women With Polycystic Ovary Syndrome: The Role of a Pulse-Based Diet and Aerobic Exercise on Infertility Measures and Metabolic Syndrome Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women With PCOS	NCT05428566	Polycystic Ovar... Metabolic Syndr...	Pulse-based die... TLC diet	18 Years - 35 Years	University of Jordan
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise	NCT01288638	Polycystic Ovar... Metabolic Syndr...	Pulse-based die... TLC diet	18 Years - 35 Years	University of Saskatchewan
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise	NCT01288638	Polycystic Ovar... Metabolic Syndr...	Pulse-based die... TLC diet	18 Years - 35 Years	University of Saskatchewan
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise	NCT01288638	Polycystic Ovar... Metabolic Syndr...	Pulse-based die... TLC diet	18 Years - 35 Years	University of Saskatchewan

Spots Global Cancer Trial Database for tlc diet

Every month we try and update this database with for tlc diet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tlc diet

Every month we try and update this database with for tlc diet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tlc diet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.