A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- •Aged 18-35 years
排除标准
- •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.
研究组 & 干预措施
Pulse-based diet
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.
干预措施: Pulse-based diet (Dietary Supplement)
TLC diet
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.
干预措施: TLC diet (Dietary Supplement)
结局指标
主要结局
Blood pressure
时间窗: Change from Baseline Systolic Blood Pressure at 3 months
In mmHg.(Systolic and Diastolic)
Blood concentration of androgen hormone
时间窗: Change from Baseline sample at 3 months
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Ovulatory dysfunction
时间窗: During nine months
Assessed by measuring the duration of the menstrual cycle
Lipid profile
时间窗: Change from Baseline sample at 3 months
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Physical activity
时间窗: 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)
Ovarian volume
时间窗: Change from Baseline ovarian morphology at 3 months
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Change in fat mass
时间窗: 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
次要结局
未报告次要终点
研究者
Shatha Hammad, Assistant Professor
Assistant Professor
University of Jordan