Apply to Trial

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Diet With Inulin for Obesity

Overseen ByCaryn 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Is inulin safe for human consumption?

Inulin is generally considered safe for human consumption and is widely used as a dietary fiber in foods. It is well tolerated up to 20 grams per day, though high doses may cause intestinal discomfort like increased gas. No toxic effects have been found in studies, and it is accepted as a food ingredient without restrictions in many countries.¹ ² ³ ⁴ ⁵

How does the treatment with Inulin differ from other obesity treatments?

Inulin is a type of dietary fiber that can enhance the feeling of fullness, which may help people stick to their diet plans. Unlike some other obesity treatments that involve drugs or surgery, Inulin is a natural fiber that can be added to the diet to support weight management.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The objective of this trial is to assess the effects of a 7-day diet containing inulin vs. a control diet on energy expenditure in adults with overweight/obesity or normal weight.

Research Team

Kevin C Maki, PhD

Principal Investigator

MB Clinical Research and Consulting LLC

Eligibility Criteria

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.

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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.

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Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Inulin - high fiberExperimental Treatment1 Intervention

Group II: Control - Low FiberActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

Recruited

880+

General Mills

Industry Sponsor

Trials

Recruited

1,800+

Findings from Research

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]

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]

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]