A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Gut Microbiome Composition
研究概览
简要总结
This study aims to evaluate the effects of 2 weeks of inulin supplementation in perimenopausal women with overweight or obesity. The primary questions this study seeks to answer are:
- Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo?
- Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo?
- Does 2 weeks of inulin supplementation affect skeletal muscle health compared with placebo?
Researchers will compare inulin with a placebo (a similar-looking supplement that does not contain inulin) to determine whether inulin influences gut and vaginal microbial function, cardiovascular health, and skeletal muscle health during the perimenopausal transition.
Participants will:
- Take either inulin or a placebo for 2 weeks, followed by a 2- to 4-week washout period, and then switch to the other supplement for an additional 2 weeks.
- Attend 8 study visits over approximately 12 to 16 weeks for assessments and sample collection.
- Complete weekly phone calls to monitor symptoms, supplement adherence, and dietary intake.
- Wear a Fitbit device throughout the study to monitor physical activity.
详细描述
This proposal presents a proof-of-concept study of the Prebiotic Inulin for Late Reproductive Individuals (PILI) intervention, a prebiotic fiber supplementation among women with perimenopause and overweight or obesity.
More specifically, the PILI intervention integrates multi-omics, physiological, and cardiometabolic assessments to examine the effects of inulin supplementation on overall health during the menopausal transition. Outcomes include changes in the gut and vaginal microbiome and their functional activity, gut-derived metabolites, vascular health, metabolic flexibility, skeletal muscle oxidative capacity, body composition, physical activity, sleep, dietary intake, and other cardiometabolic health markers. The target age range for this intervention is 40-55 years, reflecting the perimenopausal stage of life. Participants must also have overweight or obesity.
Participants will be randomly assigned to receive both the study intervention, inulin, and placebo, in a blind crossover design. Each participant will complete two intervention periods, separated by a washout period, allowing every participant to serve as her own control. Throughout the study, participants will consume the assigned supplement daily and attend scheduled in-person research visits before and after each intervention period.
At these visits, the research team will collect biological samples, including blood, stool, and vaginal swabs, and perform a comprehensive series of clinical assessments. These assessments include body composition, vascular health, metabolic flexibility, skeletal muscle oxidative capacity using near-infrared spectroscopy, physical function, and cardiometabolic testing. Participants will also complete questionnaires related to dietary intake, physical activity, sleep, menopausal symptoms, and quality of life, while wearing a Fitbit device to objectively monitor physical activity and sleep throughout the study.
The PILI study team will evaluate the feasibility of the intervention by assessing recruitment, retention, adherence to supplement consumption and study procedures, participant acceptability and tolerability, and completion of biological sample collection and clinical assessments. Preliminary changes in microbiome composition and function, microbial metabolites, and cardiometabolic health outcomes will also be evaluated to generate data that will inform the design of a future larger clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index: 25 - 40 kg/m2;
- •Menstrual cycle irregularity (cycle length outside 21 - 35 days or variation > 7 days) or/and ≥ 2 skipped cycles and interval of ≥ 60 days of amenorrhea; with or without hot flashes or/and night sweats;
- •Weight stable within the last 3 months (body weight fluctuations within the 5% of their habitual body weight);
- •Spending ≥ 6 hours sitting;
- •< 150 minutes per week (50 minutes per day, 3 days per week OR 30 minutes per day, 5 days per week) of moderate to vigorous structured physical activity (i.e., planned intentional physical activity, not incidental movement).
排除标准
- •Recent antibiotic use oral or vaginal (≥ 6months);
- •Diagnosed with any chronic disease (e.g., any gastrointestinal condition like IBD, type 2 diabetes, or cancer);
- •Prescription of hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications, or weight loss medications
- •Recent blood donation (within the past 8-12 weeks);
- •Significant weight changes (≥5%) in the last 4 weeks;
- •Use of dietary supplements (unless discontinued 4 weeks prior);
- •Participants taking long-term, stable medications for chronic conditions such as hypertension or hyperlipidemia will not be excluded if their medication regimen has been unchanged for at least 2 years, as these treatments are part of their usual health status. Recent medication changes (within the past 6 months), initiation of new prescriptions, or use of medications known to affect metabolic, vascular, vaginal, hormonal, or gastrointestinal function will result in exclusion.
- •Fructose intolerance.
研究组 & 干预措施
Sequence A (Inulin → Placebo)
Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.
干预措施: Inulin (Dietary Supplement)
Arm 2: Sequence B (Placebo → Inulin)
Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks.
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
Arm 2: Sequence B (Placebo → Inulin)
Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks.
干预措施: Inulin (Dietary Supplement)
Sequence A (Inulin → Placebo)
Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
结局指标
主要结局
Change in Gut Microbiome Composition
时间窗: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).
Change in gut microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Change in Gut Microbiome Functional Capacity
时间窗: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).
Change in gut microbiome functional capacity, including biosynthetic gene clusters (BGCs) and estrobolome-related microbial pathways, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Change in Vaginal Microbiome Composition
时间窗: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).
Change in vaginal microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
次要结局
- Vascular Function(Baseline and end of each 2-week intervention period (inulin and placebo), with assessments conducted during each intervention period following the washout phase (2-4 weeks).)
- Metabolic Flexibility(Baseline and end of each 2-week intervention period (inulin and placebo), with assessments conducted during each intervention period following the washout phase (2-4 weeks).)
- Skeletal muscle mitochondrial oxidative capacity(Baseline and end of each 2-week intervention period (inulin and placebo), with assessments conducted during each intervention period following the washout phase (2-4 weeks))
研究者
Carmen Ortega-Santos
Assistant Professor
George Washington University