Diet With Inulin for Obesity

Overseen By Caryn G Adams, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Must not be taking: Alpha-blockers, Beta-blockers, Diuretics, others

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a diet with inulin, a type of fiber, compares to a low-fiber diet in affecting energy use in people. It targets adults who are of normal weight or have overweight or obesity. Participants should not have extreme dietary habits, such as a very high fiber diet, and should not use tobacco or certain medications. The goal is to determine if inulin can help manage weight by influencing energy use in the body. As an unphased trial, this study allows participants to contribute to important research on dietary impacts on energy use and weight management.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but certain medications and supplements that affect metabolism, heart rate, or are related to weight loss must be stopped before the trial. There are specific washout periods for some substances, like a 14-day period for fiber supplements and a 30-day period for certain heart and metabolism-related medications.

What prior data suggests that this diet is safe for adults with overweight/obesity or normal weight?

Studies have shown that inulin, a type of dietary fiber, is generally safe for use. Research indicates that inulin does not cause major side effects when included in a diet. For example, experts found that inulin-propionate ester, a form of inulin, is safe for most people when used correctly. While inulin is mainly used for its health benefits, such as aiding weight loss and building muscle, these studies also confirm its safety. Overall, evidence suggests that most people can tolerate inulin well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obesity, which often include medications and lifestyle changes, inulin offers a natural, fiber-based approach. Inulin is a type of dietary fiber that can enhance gut health and promote a feeling of fullness, potentially helping with weight management. Researchers are excited because inulin could provide a safer, more holistic alternative with fewer side effects, supporting weight loss through improved digestive health and appetite regulation.

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

Research has shown that inulin can aid in weight loss. A review of several studies found that people who consumed inulin-like fibers lost weight, had a lower body mass index (BMI), and reduced body fat. Inulin also appears to decrease belly fat and improve how the body processes sugar. In this trial, participants will follow either a high-fiber diet with inulin or a low-fiber control diet. Previous studies suggest that diets including inulin led to more weight loss and better health outcomes compared to diets without it. These findings indicate that inulin may be effective for managing obesity. ^{2 6 7 8 9}

Who Is on the Research Team?

Kevin C Maki, PhD

Principal Investigator

MB Clinical Research and Consulting LLC

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 who are either overweight with a BMI of 27.0 to 34.9 or have a normal weight with a BMI of 18.5 to 24.9. Women must have regular menstrual cycles if not using hormonal contraceptives, and all participants should be in good health and willing to follow the study procedures.

Inclusion Criteria

Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.

Individual is willing and able to undergo the scheduled study procedures.

Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria

Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.

Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important GI, cardiac, renal, hepatic, endocrine (i.e., diabetes), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator. Clinically important GI conditions included but are not limited to: inflammatory bowel disease, irritable bowel syndrome, gastroparesis, clinically important lactose intolerance.

Individual habitually consumes >8 g fiber per 1000 kcal per day. A 14-day washout prior to the first test and throughout the study period is permitted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - Inulin Diet

Participants follow a 7-day diet containing inulin to assess its effects on energy expenditure

7 days

1 visit (in-person) on day 7

Washout

Participants undergo a washout period between diet phases

7 days

Treatment - Control Diet

Participants follow a 7-day control diet to assess its effects on energy expenditure

7 days

1 visit (in-person) on day 21

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inulin

Trial Overview The trial is testing the effects on energy expenditure of two different diets over seven days: one includes a high-fiber bar with inulin (a type of dietary fiber), while the other diet has a low-fiber bar without inulin.

How Is the Trial Designed?

Group I: Inulin - high fiber Experimental Treatment 1 Intervention

Group II: Control - Low Fiber Active Control 1 Intervention

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

22

Recruited

880+

General Mills

Industry Sponsor

Trials

24

Recruited

1,800+

Published Research Related to This Trial

Inulin-type fructans, particularly oligofructose-enriched inulin, are effective prebiotics that enhance gut health by promoting the growth of beneficial bacteria and improving bowel habits, supported by numerous animal studies and human trials.

Inulin has been shown to reduce triglyceride levels in the blood and may help normalize blood lipids, with potential implications for reducing the risk of colon cancer, as ongoing human trials are investigating its effects in individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing inulin-type fructans. Roberfroid, MB.[2021]

Low-fat diets in obese patients result in modest weight loss of 3-4 kg over 3 years, while calorie-controlled diets show better outcomes with 6-7 kg weight loss at 4 years, although long-term data is limited.

Bariatric surgery, such as gastric bypass, can lead to significant weight loss (up to 25% over 10 years) and reduce mortality and comorbidities, but it carries risks of nutritional deficiencies and gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary treatment for obesity. Clifton, PM.[2022]

Inulin fructans, derived from chicory root, are safe and well-tolerated dietary fibers that can be consumed up to 20 g per day, providing various health benefits.

They have direct effects on gut health, such as improving bowel function and promoting beneficial gut bacteria, as well as indirect effects on blood lipids and the immune system, suggesting potential for further research in energy balance and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of Inulin Fructans in the Human Diet. Schaafsma, G., Slavin, JL.[2021]

Inulin and oligofructose are widely considered safe food ingredients, with no toxic effects found in high-dose animal tests, and they are accepted for unrestricted use in food formulations by legal authorities globally.

While daily intakes are generally safe, high doses can lead to intestinal discomfort, such as increased flatulence, which varies among individuals and depends on the food type, highlighting the importance of moderation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin and oligofructose: safe intakes and legal status. Coussement, PA.[2018]

Citations

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Inulin accelerates weight loss in obese mice by regulating ... Inulin supplementation could accelerate body weight loss in obese mice by increasing Alistipes and indole-3-acrylic acid level.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916524007512

The effects of chicory inulin-type fructans supplementation ... Our systematic review and meta-analysis of 32 studies showed that the consumption of ITF led to significant reductions in body weight, BMI, fat mass, waist ...

3. nature.com nature.com/articles/s41598-022-17220-0

Effects of inulin supplementation on body composition and ... A systematic review and meta-analysis revealed significant reductions in BMI, body weight, and body fat after soluble fiber supplementation in ...

4. nutritionandmetabolism.biomedcentral.com nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-022-00685-1

Inulin reduces visceral adipose tissue mass and improves ... Inulin altered the gut metabolites and reduced visceral adipose tissue, thereby resulting in improved glucose tolerance.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11972196/

Interest of inulin in obesity: comparison of the prebiotic ... Compared to placebo, the inulin-enriched diet was more efficient to improve some clinical outcomes (weight loss, diastolic blood pressure, AST ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287749/

Safety of inulin‐propionate ester as a novel food pursuant ... The Panel concludes that the NF, inulin‐propionate ester, is safe for the general population under the proposed conditions of use.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0261561420301606

Link between gut microbiota and health outcomes in inulin ... Conclusions. Inulin-enriched diet is able to promote weight loss in obese patients, the treatment efficiency being related to gut microbiota characteristics.

8. nutritionandmetabolism.biomedcentral.com nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-00995-0

The effects of inulin supplementation on eating behaviours in ... Inulin supplementation exhibits increased muscle mass via gut-muscle axis in children with obesity: double evidence from clinical and in vitro ...

9. efsa.onlinelibrary.wiley.com efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2025.9534

Safety of inulin‐propionate ester as a novel food pursuant to ... The Panel concludes that the NF, inulin-propionate ester, is safe for the general population under the proposed conditions of use. Supporting ...