Prebiotic Inulin for Late-Reproductive Individuals

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT07724522
Status
Recruiting
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Conditions

  • Cardiovascular Diseases (CVD)
  • Dietary Fiber
  • Gastrointestinal Microbiome
  • Insulin Resistance
  • Inulin
  • Microbiota
  • Muscle, Skeletal
  • Obesity & Overweight
  • Perimenopausal Women
  • Prebiotics
  • Vascular Health
  • Women Health

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Inulin — DIETARY_SUPPLEMENT
    10g per day for 2 weeks
  • Maltodextrin (Placebo) — DIETARY_SUPPLEMENT
    10g per day for 2 weeks

Study Details

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.

Key Dates

First listed
Jul 24, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

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.

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Milken Institute School of Public HealthWashington D.C.District of Columbia20052
Carmen Ortega-Santos, PhD, RD
[email protected]
202-994-2757

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By research site
Milken Institute School of Public Health· Washington D.C., DC

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