20 Participants Needed

Fiber Supplement 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 explores whether a fiber supplement called inulin can improve blood vessel health in people with obesity. Researchers aim to determine if the benefits vary between individuals with few heart disease risk factors and those with several. Participants will take the inulin powder daily for nine weeks. This trial suits individuals with a BMI of 30 or higher who do not have major heart or inflammatory conditions and can avoid certain medications and supplements. As an unphased trial, it offers participants the chance to contribute to important research that could enhance health outcomes for people with obesity.

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

You may need to stop taking anti-inflammatory drugs for 3 days before lab visits, and you cannot take weight-loss medications. The trial does not mention other medications, so it's best to ask the trial team for more details.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that inulin, a type of fiber that supports beneficial gut bacteria, is generally safe for most people. In past studies, participants took up to 50 grams daily without serious problems. In this trial, participants will begin with 6 grams and increase to 12 grams daily. Most people tolerate these amounts without issues. If side effects occur, they might include mild digestive problems like gas or bloating, which are usually not serious and often subside as the body adjusts to the fiber. This makes inulin a well-tolerated choice for many.12345

Why are researchers excited about this trial?

Unlike the standard obesity treatments, which often involve medications or surgical interventions, inulin is a natural fiber supplement derived from chicory root. Researchers are excited about inulin because it works by promoting a feeling of fullness and supporting gut health, which may help regulate weight without the need for pharmaceuticals. Additionally, its simple delivery method—mixed into a daily beverage—makes it easy to incorporate into daily routines, potentially enhancing adherence and effectiveness.

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

Research has shown that inulin, a type of fiber from chicory root, can aid in weight management. Some studies suggest that chicory inulin helps people with obesity lose weight, lower their BMI, reduce body fat, and shrink waist size. It may also reduce food intake, supporting weight loss. This fiber improves gut health, which is crucial for managing weight. Additionally, the weight loss benefits of chicory root fiber might increase over time. Participants in this trial will consume inulin to evaluate its effects on obesity.678910

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 with obesity (BMI ≥30 kg/m2) who can lie on their back in the dark for vascular measurements. They shouldn't have used antibiotics or probiotics recently, be postmenopausal, take certain medications, use tobacco or illicit drugs, have food allergies to fiber supplements, or chronic inflammatory conditions.

Inclusion Criteria

I don't regularly use anti-inflammatory drugs more than twice a week and can stop taking them for 3 days before lab visits.
I am not taking any weight-loss medications.
Participants have not used antibiotics or probiotics in the last month
See 11 more

Exclusion Criteria

Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims
I have a chronic inflammatory condition like rheumatoid arthritis or IBD.
I have been diagnosed with a serious heart or metabolic condition.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants consume 6g of inulin per day as a run-in period

1 week
1 visit (in-person)

Treatment

Participants consume 12g of inulin per day for 8 weeks

8 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inulin
Trial Overview The study tests if supplemental fiber (inulin) over 9 weeks improves vascular health in obese individuals and how it varies based on heart disease risk factors. It compares those with few versus several risk factors outside normal ranges like blood pressure and cholesterol.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Inulin SupplementExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ball State University

Lead Sponsor

Trials
10
Recruited
670+

Citations

The effects of chicory inulin-type fructans supplementation ...Chicory ITF supplementation may benefit weight management by reducing body weight, BMI, fat mass, waist circumference, and to a certain extent body fat ...
Interest of inulin in obesity: comparison of the prebiotic ...Results. Both inulin sources reduced food intake without significantly modifying body weight gain or adiposity compared to HF. Purified inulin ...
Chicory root fibers supports weight managementStudies confirm that chicory root fiber significantly helps reduce body weight, BMI, fat mass, waist circumference, and body fat percentage.
Prebiotic chicory root fiber found to boost weight loss via “ ...In addition, the review concluded that chicory root fiber's weight loss effectiveness was not reduced over time but became even more pronounced.
Intrinsic chicory root fibers modulate colonic microbial ...We have employed a robust randomized controlled trial using this intrinsic fiber in individuals with obesity at high risk of developing T2D ...
Back to the Roots: Revisiting the Use of the Fiber-Rich ...As a prebiotic fiber, inulin has been tested up to an intake of >50 g per day (113) and concluded to be safe (111). The only concerns comprised ...
Inulin - Uses, Side Effects, and MoreWhen taken by mouth: Inulin is likely safe for most people in the amounts found in foods. It is possibly safe in adults when taken as a supplement, short-term.
Intrinsic chicory root fibers modulate colonic microbial ...Intrinsic chicory root fibers modulate colonic microbial butyrate-producing pathways and improve insulin sensitivity in individuals with obesity.
Inulin (a prebiotic fiber): Health benefits and risksResearchers have studied the different forms of inulin extensively, and it appears to be safe for most people in small doses. However, people who are intolerant ...
The effects of chicory inulin-type fructans supplementation on ...Chicory ITF supplementation may benefit weight management by reducing body weight, BMI, fat mass, waist circumference, and to a certain extent body fat ...
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