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临床试验/NCT04680325
NCT04680325已完成不适用

Impact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women

University of Arkansas, Fayetteville2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Changes in the gut microbiota profile assessed by sequencing of stool samples

研究概览

简要总结

This study was a randomized, placebo-controlled, crossover, pilot dietary intervention. Ocean Spray Cranberries, Inc provided the experimental and placebo beverages, which have been validated and used in previous studies [26-29]. Both beverages were similar in appearance, taste, and aroma and assigned to volunteers according to computer-generated random orders. Both investigators and participants were blind to the assignment and products are identified by a random 3-digit code pre-printed on the cap. The participants consumed either cranberry juice or placebo beverage daily (8 fl oz per day) for 15 days

详细描述

This was a prospective exploratory pilot study with a dietary intervention. Twenty-three (23) women volunteered and participated in this study. The eligibility (no menstrual period for at least 12 months) of the participants was determined using a questionnaire. The participants were postmenopausal women between the ages of 50-75 years old who met the exclusion criteria including no recent antibiotics or immunosuppressive therapies, surgery of the stomach, small or large intestines, appendectomy, gastric bypass or gastric banding in the previous 6 months, and diagnostic with any autoimmune diseases.

This study was a randomized, placebo-controlled, crossover, pilot dietary intervention. Ocean Spray Cranberries, Inc provided the experimental and placebo beverages, which have been validated and used in previous studies [26-29]. Both beverages were similar in appearance, taste, and aroma and assigned to volunteers according to computer-generated random orders. Both investigators and participants were blind to the assignment and products are identified by a random 3-digit code pre-printed on the cap. The participants consumed either cranberry juice or placebo beverage daily (8 fl oz per day) for 15 days

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Post-menopausal status

排除标准

  • recent (6months) antibiotics or immunosuppressive therapies
  • recent (6months) abdominal surgeries

结局指标

主要结局

Changes in the gut microbiota profile assessed by sequencing of stool samples

时间窗: 4 weeks

Changes in the vaginal microbiota profile assessed by sequencing of swab samples

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Franck

Assistant Professor

University of Arkansas, Fayetteville

研究点 (2)

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