Obesity & OverweightPILINCT07724522
Prebiotic Inulin for Late-Reproductive Individuals
A study testing Inulin in people with Obesity & Overweight and Perimenopausal Women, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Obesity & Overweight, Perimenopausal Women, Prebiotics
- What is being tested?
- Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Milken Institute School of Public Health
Washington D.C., District of Columbia, 20052
Carmen Ortega-Santos, PhD, RD, 202-994-2757, fitgutlab@gwu.edu
About this study
Official title: A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
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?
Read more
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.
Read the detailed description
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.
This research has the potential to advance understanding of how prebiotic supplementation influences the gut-muscle-metabolism axis during the menopausal transition and to identify a safe, low-cost nutritional strategy to improve cardiometabolic health among perimenopausal women.
- Conditions
- Obesity & Overweight, Perimenopausal Women, Prebiotics, Inulin, Muscle, Skeletal, Cardiovascular Diseases (CVD)
- Being tested
- Inulin, Maltodextrin (Placebo)
- Keywords
- Perimenopause, Nutrition, Menopause transition, Overweight, Obesity, Cardiometabolic Health, Vascular function, Randomized Controlled Trial, Gut microbiome, Vaginal microbiome, Supplements, Inulin, Vascular Health
- Medical subject headings
- Obesity, Overweight, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
10g per day for 2 weeks
Maltodextrin (Placebo)Dietary supplement
10g per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiome Composition
Change in gut microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Measured: 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.
Measured: 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.
Measured: Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).
Secondary outcomes (3)
Vascular Function
Change in vascular function, assessed by pulse-wave velocity (PWV), comparing inulin versus placebo in a randomized crossover design.
Measured: 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
Change in metabolic flexibility, assessed as the change in respiratory exchange ratio (RER) from the fasted resting state to the postprandial period following a standardized high-fat mixed meal, measured continuously via indirect calorimetry, comparing inulin versus placebo in a randomized crossover design.
Measured: 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
Change in skeletal muscle mitochondrial oxidative capacity in the gastrocnemius muscle, comparing inulin versus placebo in a randomized crossover design. Muscle oxidative capacity will be assessed using near-infrared spectroscopy (NIRS).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blinded Cross-Over Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Ortega-Santos, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724522
- Sponsor's protocol ID
- NCR267325
- Other IDs
- 05RIA112025
- Acronym
- PILI
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains sensitive health and behavioral information, and full de-identification and public release are not planned within the scope of this study.
Publications
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.
PubMed 38170622Wang 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.
PubMed 40551890Houghton 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.
PubMed 30183376Cross 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.
PubMed 38153260Cavallari 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.
PubMed 31089513Cabre 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.
PubMed 35762156Gould 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.
PubMed 35231009Le 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.
PubMed 31707507Peters 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.
PubMed 35983178Ervin 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.
PubMed 31636122El 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.
PubMed 33251828
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07724522
- Acronym / sponsor ID
- PILI / NCR267325
- Conditions
- Obesity & Overweight, Perimenopausal Women, Prebiotics, Inulin, Muscle, Skeletal, Cardiovascular Diseases (CVD)
- Keywords
- Perimenopause, Nutrition, Menopause transition, Overweight, Obesity, Cardiometabolic Health, Vascular function, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This research has the potential to advance understanding of how prebiotic supplementation influences the gut-muscle-metabolism axis during the menopausal transition and to identify a safe, low-cost nutritional strategy to improve cardiometabolic health among perimenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blinded Cross-Over Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Sequence A (Inulin → Placebo) | Experimental | Dietary Supplement: Inulin, Dietary Supplement: Maltodextrin (Placebo)Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks. |
| Arm 2: Sequence B (Placebo → Inulin) | Experimental | Dietary Supplement: Inulin, Dietary Supplement: Maltodextrin (Placebo)Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin10g per day for 2 weeks | Dietary supplement | Arm 2: Sequence B (Placebo → Inulin), Sequence A (Inulin → Placebo) |
| Maltodextrin (Placebo)10g per day for 2 weeks | Dietary supplement | Arm 2: Sequence B (Placebo → Inulin), Sequence A (Inulin → Placebo) |
Primary outcome
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 composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
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 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
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, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
3 secondary outcomes
Vascular Function
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 38170622Huang 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.
- Results publication: PubMed 40551890Wang 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.
- Results publication: PubMed 30183376Houghton 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.
- Results publication: PubMed 38153260Cross 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.
- Results publication: PubMed 31089513Cavallari 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.
- Results publication: PubMed 35762156Cabre 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.
- Results publication: PubMed 35231009Gould 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.
- Results publication: PubMed 31707507Le 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.
- Results publication: PubMed 35983178Peters 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.
- Results publication: PubMed 31636122Ervin 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.
- Results publication: PubMed 33251828El 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.
- Participation Interest QuestionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains sensitive health and behavioral information, and full de-identification and public release are not planned within the scope of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin in people with Obesity & Overweight and Perimenopausal Women, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Ortega-Santos, PhD, RD (202-994-2757, fitgutlab@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07724522, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.