70 Participants NeededMy employer runs this trial

Inulin Supplementation for Obesity

BK
Overseen ByBryant Keirns, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a prebiotic fiber called inulin affects the gut, immune system, and blood vessels in individuals with obesity who have a healthy metabolism. Researchers aim to understand the impact of a high-fat meal on these systems in both metabolically healthy individuals with obesity and those of normal weight. The trial suits individuals with obesity and a normal metabolism who do not have conditions like diabetes or heart disease and who do not take certain medications. Participants should also be able to consume a provided meal without dietary restrictions. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding without the constraints of traditional clinical trial phases.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. You cannot use lipid-lowering drugs, glucose-lowering drugs, anti-hypertensive drugs, or weight-loss drugs. If you take anti-inflammatory drugs, you must be able to stop them three days before the study visit.

Is there any evidence suggesting that inulin supplementation is likely to be safe?

Research has shown that inulin supplements are generally well-tolerated. A review of several studies found that inulin can aid in weight and body fat reduction without major side effects. Another study demonstrated that inulin can enhance insulin utilization and reduce inflammation markers, benefiting overall health.

These studies suggest that inulin is safe for use, with no serious issues reported. The trial's "Not Applicable" phase designation likely indicates a focus on understanding specific outcomes rather than basic safety testing, reflecting confidence in inulin's safety.12345

Why are researchers excited about this trial?

Unlike standard obesity treatments that often involve medications like orlistat, phentermine, or lifestyle changes, inulin supplementation is unique because it harnesses a naturally occurring dietary fiber. Inulin works differently by acting as a prebiotic, which nourishes beneficial gut bacteria, potentially leading to improved metabolism and weight management. Researchers are excited about inulin because it offers a natural, non-pharmacological approach that could complement existing treatments while potentially having fewer side effects.

What evidence suggests that inulin might be an effective treatment for obesity?

Research has shown that inulin supplements can aid in weight management and improve body shape. A review of studies found that inulin led to noticeable reductions in body mass index (BMI), body weight, and body fat. Inulin may also enhance gut health and help control appetite, which can be useful for managing obesity. Another study found that inulin aids weight loss by influencing gut bacteria, which play a crucial role in digestion and metabolism. Additionally, inulin has been shown to lower blood sugar levels and improve insulin utilization, potentially reducing health risks linked to obesity. These findings suggest that inulin could benefit people with obesity. Participants in this trial will be divided into two groups: the Metabolically Healthy Obesity Group and the Metabolically Healthy Normal Weight Group, to assess the effects of inulin supplementation in different metabolic contexts.12346

Who Is on the Research Team?

BK

Bryant Keirns, PhD

Principal Investigator

Ball State University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 who are either normal weight or have obesity but are otherwise healthy, with no major heart, metabolic, inflammatory, or gut diseases. Participants can't be pregnant, postmenopausal (for women), on certain medications like statins or diabetes drugs, or recent users of antibiotics/probiotics.

Inclusion Criteria

* Have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol").
I have not been diagnosed with heart disease or type 2 diabetes.
I do not have any chronic inflammatory or digestive diseases.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Meal Trial

Participants complete a meal trial involving a high-fat meal and multiple blood sample collections to assess various biomarkers.

1 day
1 visit (in-person)

Intervention

Participants receive 6 weeks of supplemental inulin or placebo with assessments at 2-, 4-, and 6-weeks.

6 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inulin

Trial Overview

The study looks at how a single high-fat meal affects gut, immune, and blood vessel health in people with healthy obesity versus those of normal weight. It also tests if taking the fiber supplement inulin changes these responses compared to a placebo (maltodextrin).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Metabolically Healthy Obesity GroupExperimental Treatment3 Interventions
Group II: Metabolically Healthy Normal Weight GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ball State University

Lead Sponsor

Trials
10
Recruited
670+

Citations

Effects of inulin supplementation on body composition ... - PMC

A recent systematic review and meta-analysis revealed significant reductions in BMI, body weight, and body fat after soluble fiber ...

Inulin Supplementation for Obesity

The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with ...

The effects of inulin supplementation on eating behaviours in ...

Inulin supplementation may restore gut microbiota dysbiosis and modulate appetite control in childhood obesity. This study evaluated the effects ...

Link between gut microbiota and health outcomes in inulin ...

Inulin-enriched diet is able to promote weight loss in obese patients, the treatment efficiency being related to gut microbiota characteristics.

Baseline gut microbiota may determine inulin effects on ...

New findings in mice and people with obesity show that 'responders' to inulin may be identifiable from their gut microbiota.

Health Effects and Mechanisms of Inulin Action in Human ...

Inulin supplementation contributes to body weight and BMI control, reduces blood glucose levels, improves insulin sensitivity, and reduces inflammation markers.