Recruiting

Inulin

Sponsor:

George Washington University

Code:

NCT07724522

Conditions

Obesity & Overweight

Perimenopausal Women

Prebiotics

Inulin

Muscle, Skeletal

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Not accepted

Interventions

Inulin

Maltodextrin (Placebo)

Study Details

Brief summary:

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:

1. Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo?
2. Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo?
3. 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.

Conditions

Obesity & Overweight

Perimenopausal Women

Prebiotics

Inulin

Muscle, Skeletal

Study ID

NCT07724522

Start date

Aug 1, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • Smoking;
  • 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.

Study Design

Enrollment

27 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sequence A (Inulin → Placebo)

Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.

experimental: 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.

Interventions

Inulin

10g per day for 2 weeks

Maltodextrin (Placebo)

10g per day for 2 weeks

Primary outcome measure

  • Change in Gut Microbiome Composition [ Time Frame: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks). ]
  • Change in Gut Microbiome Functional Capacity [ Time Frame: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks). ]
  • Change in Vaginal Microbiome Composition [ Time Frame: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks). ]

Central Contacts and Locations

Central contacts

Carmen Ortega-Santos, PhD, RD

202-994-2757fitgutlab@gwu.edu

Locations

Milken Institute School of Public Health

Recruiting

Washington D.C., District of Columbia, United States, 20052

Contacts

Carmen Ortega-Santos, PhD, RD

202-994-2757fitgutlab@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Perimenopause
  • Nutrition
  • Menopause transition
  • Overweight
  • Obesity
  • Cardiometabolic Health
  • Vascular function
  • Randomized Controlled Trial
  • Gut microbiome
  • Vaginal microbiome
  • Supplements
  • Inulin
  • Vascular Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by George Washington University on 2026-08-11.