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Prebiotic Inulin for Late-Reproductive Individuals

NCT07724522 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-08-11

No results posted yet for this study

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
  • Cardiovascular Diseases (CVD)
  • Microbiota
  • Gastrointestinal Microbiome
  • Dietary Fiber
  • Women Health
  • Vascular Health
  • Insulin Resistance

Interventions

DIETARY_SUPPLEMENT

Inulin

10g per day for 2 weeks

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

10g per day for 2 weeks

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724522 on ClinicalTrials.gov