Prebiotic Inulin for Late-Reproductive Individuals

NCT07724522 | Recruiting

• 2 other identifiers: NCR26732505RIA112025
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Gut Microbiome Composition

  Change in gut microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.

  Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).

• Change in Gut Microbiome Functional Capacity

  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.

  Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).

• Change in Vaginal Microbiome Composition

  Change in vaginal microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.

  Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).

Secondary Outcomes (3)

• 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)

Study Arms (2)

Sequence A (Inulin → Placebo)

EXPERIMENTAL

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

Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin (Placebo)

Arm 2: Sequence B (Placebo → Inulin)

EXPERIMENTAL

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

Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin (Placebo)

Interventions

Inulin DIETARY_SUPPLEMENT

10g per day for 2 weeks

Arm 2: Sequence B (Placebo → Inulin); Sequence A (Inulin → Placebo)

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

10g per day for 2 weeks

Arm 2: Sequence B (Placebo → Inulin); Sequence A (Inulin → Placebo)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• Fructose intolerance.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health

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

RECRUITING

Related Publications (11)

• Huang F, Cao Y, Liang J, Tang R, Wu S, Zhang P, Chen R. The influence of the gut microbiome on ovarian aging. Gut Microbes. 2024 Jan-Dec;16(1):2295394. doi: 10.1080/19490976.2023.2295394. Epub 2024 Jan 3.

  PMID: 38170622 RESULT

• Wang H, Shi F, Zheng L, Zhou W, Mi B, Wu S, Feng X. Gut microbiota has the potential to improve health of menopausal women by regulating estrogen. Front Endocrinol (Lausanne). 2025 Jun 9;16:1562332. doi: 10.3389/fendo.2025.1562332. eCollection 2025.

  PMID: 40551890 RESULT

• Houghton MJ, Kerimi A, Mouly V, Tumova S, Williamson G. Gut microbiome catabolites as novel modulators of muscle cell glucose metabolism. FASEB J. 2019 Feb;33(2):1887-1898. doi: 10.1096/fj.201801209R. Epub 2018 Sep 5.

  PMID: 30183376 RESULT

• Cross TL, Simpson AMR, Lin CY, Hottmann NM, Bhatt AP, Pellock SJ, Nelson ER, Loman BR, Wallig MA, Vivas EI, Suchodolski J, Redinbo MR, Rey FE, Swanson KS. Gut microbiome responds to alteration in female sex hormone status and exacerbates metabolic dysfunction. Gut Microbes. 2024 Jan-Dec;16(1):2295429. doi: 10.1080/19490976.2023.2295429. Epub 2023 Dec 28.

  PMID: 38153260 RESULT

• Cavallari JF, Schertzer JD. Intestinal Microbiota Contributes to Energy Balance, Metabolic Inflammation, and Insulin Resistance in Obesity. J Obes Metab Syndr. 2017 Sep;26(3):161-171. doi: 10.7570/jomes.2017.26.3.161. Epub 2017 Sep 30.

  PMID: 31089513 RESULT

• Cabre HE, Gould LM, Gordon AN, Giuliani-Dewig HK, Moore SR, Ryan ED, Smith-Ryan AE. Differences in strength, leg lean mass, and lifestyle factors between premenopausal and perimenopausal women. Clin Physiol Funct Imaging. 2022 Nov;42(6):460-464. doi: 10.1111/cpf.12771. Epub 2022 Jul 26.

  PMID: 35762156 RESULT

• Gould LM, Gordon AN, Cabre HE, Hoyle AT, Ryan ED, Hackney AC, Smith-Ryan AE. Metabolic effects of menopause: a cross-sectional characterization of body composition and exercise metabolism. Menopause. 2022 Feb 28;29(4):377-389. doi: 10.1097/GME.0000000000001932.

  PMID: 35231009 RESULT

• Le Bastard Q, Chapelet G, Javaudin F, Lepelletier D, Batard E, Montassier E. The effects of inulin on gut microbial composition: a systematic review of evidence from human studies. Eur J Clin Microbiol Infect Dis. 2020 Mar;39(3):403-413. doi: 10.1007/s10096-019-03721-w. Epub 2019 Nov 9.

  PMID: 31707507 RESULT

• Peters BA, Santoro N, Kaplan RC, Qi Q. Spotlight on the Gut Microbiome in Menopause: Current Insights. Int J Womens Health. 2022 Aug 10;14:1059-1072. doi: 10.2147/IJWH.S340491. eCollection 2022.

  PMID: 35983178 RESULT

• Ervin SM, Li H, Lim L, Roberts LR, Liang X, Mani S, Redinbo MR. Gut microbial beta-glucuronidases reactivate estrogens as components of the estrobolome that reactivate estrogens. J Biol Chem. 2019 Dec 6;294(49):18586-18599. doi: 10.1074/jbc.RA119.010950. Epub 2019 Oct 21.

  PMID: 31636122 RESULT

• El Khoudary SR, Aggarwal B, Beckie TM, Hodis HN, Johnson AE, Langer RD, Limacher MC, Manson JE, Stefanick ML, Allison MA; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause Transition and Cardiovascular Disease Risk: Implications for Timing of Early Prevention: A Scientific Statement From the American Heart Association. Circulation. 2020 Dec 22;142(25):e506-e532. doi: 10.1161/CIR.0000000000000912. Epub 2020 Nov 30.

  PMID: 33251828 RESULT

Related Links

• Participation Interest Questionnaire

MeSH Terms

Conditions

Obesity; Overweight; Cardiovascular Diseases; Insulin Resistance

Interventions

Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Central Study Contacts

Carmen Ortega-Santos, PhD, RD

CONTACT

202-994-2757; fitgutlab@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Blinded Cross-Over Randomized Controlled Trial

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)