PULSE 饮食和 TLC 饮食对 PCOS 女性生殖、代谢参数的比较
基于脉冲的饮食和治疗性生活方式改变饮食对多囊卵巢综合征女性生殖和代谢参数的比较
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Amman、约旦
- Jordan University Hospital
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Amman、约旦、11942
- the university of Jordan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 女性
- 除胰岛素抵抗外还诊断 PCOS(稳态模型评估 (HOMA)-胰岛素抵抗指数 ≥ 2)。
- 18-35岁
排除标准:
- 酮饮食、素食、孕妇、哺乳期、2 级肥胖(体重指数 (BMI) ≥35)、当前吸烟者,或者患有糖尿病、心血管疾病、肾脏疾病、肝脏疾病或荷尔蒙疾病的个人。
- 至少在过去 3 个月内服用已知会影响血脂、葡萄糖或激素水平和/或体重的任何药物或补充剂的个人。
- 任何对脉冲过敏或不耐受的人。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:以豆类为主的饮食
豆类饮食将包括两顿以豆类为主的膳食;每顿豆类餐将由大约一杯非油籽豆类组成,将使用不同品种的豆类(干豆、豌豆、扁豆、羽扇豆和鹰嘴豆)。 将包括各种豆类,并向参与者提供食谱和制备想法,这将增强豆类的适口性,提供不同的口味选择,并轻松遵循规定的饮食并鼓励参与者在目标时间内食用。 饮食是等热量且均衡的,固定常量营养素组成为 28% 脂肪、55% 碳水化合物和 17% 蛋白质。 |
一种等热量、均衡的饮食,含有 28% 脂肪、55% 碳水化合物和 17% 蛋白质的固定常量营养素组成。 脉冲饮食将包括两顿基于脉冲的膳食;每份豆类餐将由大约一杯非油籽豆类组成,将使用不同种类的豆类(干豆、豌豆、扁豆、羽扇豆和鹰嘴豆)。 |
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安慰剂比较:TLC饮食
TLC 小组将获得遵循 TLC 指南的说明,并且将为每位参与者提供个性化的饮食计划样本。 健康的TLC饮食将根据每位参与者的能量水平量身定制,以达到以下营养量:饱和脂肪酸占总热量的7%以下,多不饱和脂肪占总热量的10%,最多占总热量20%的单不饱和脂肪,每天少于200毫克的胆固醇,每天至少5至10克的可溶性纤维。 饮食是等热量且均衡的,固定常量营养素组成为 28% 脂肪、55% 碳水化合物和 17% 蛋白质。 |
一种等热量、均衡的饮食,含有 28% 脂肪、55% 碳水化合物和 17% 蛋白质的固定常量营养素组成。 健康的 TLC 饮食将根据每位参与者的能量水平量身定制,以达到以下营养素含量:饱和脂肪酸总热量的 7% 以下,多不饱和脂肪总热量的 10% 以下,多不饱和脂肪的总热量最多单不饱和脂肪占总热量的 20%,胆固醇每天少于 200 毫克,可溶性纤维每天至少 5 至 10 克。 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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雄激素血药浓度
大体时间:3 个月时基线样本的变化
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雄激素;将评估 2 个研究组的所有参与者的睾丸激素
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3 个月时基线样本的变化
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卵巢体积
大体时间:3 个月时卵巢形态基线的变化
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经验丰富的超声医师将评估每个卵巢的卵巢体积。
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3 个月时卵巢形态基线的变化
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排卵障碍
大体时间:在九个月内
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通过测量月经周期的持续时间进行评估
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在九个月内
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脂质谱
大体时间:3 个月时基线样本的变化
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将评估 2 个研究组的所有参与者的血胆固醇
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3 个月时基线样本的变化
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脂肪量的变化
大体时间:3 个月时基线测量值的变化
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将使用 InBody 120(身体成分分析仪)对 2 个研究组的所有参与者进行身体成分扫描评估
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3 个月时基线测量值的变化
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体力活动
大体时间:3 个月时基线点的变化
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经过验证的国际身体活动问卷 (IPAQ) 阿拉伯语简表将用于评估所有参与者的身体活动。 总身体活动 MET-分钟/周分数可以计算为:总身体活动 MET-分钟/周 = 总(步行 + 中等 + 剧烈)MET- 分钟/周分数的总和。 ( < 4 : 低), (4-6 中等) 和 ( >6: 剧烈) |
3 个月时基线点的变化
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血压
大体时间:3 个月时基线收缩压的变化
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以毫米汞柱为单位。(收缩压和舒张压)
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3 个月时基线收缩压的变化
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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以前的饮食消费
大体时间:基线点。 (学习之初)
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所有参与者都将完成经过验证的阿拉伯食物频率问卷,以评估这些女性之前的饮食消费并将其与饮食建议进行比较。
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基线点。 (学习之初)
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合作者和调查者
调查人员
- 首席研究员:Shatha Hammad, PhD、the university of Jordan
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (估计的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2020-2019/27
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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