HealthyNCT06923332
A Trial to Assess the Effects of Diets With and Without Inulin on Energy Expenditure in Adults.
A study testing High Fiber bar with Inulin and Low fiber bar - no inulin in people with Healthy and Overweight or Obese Adults, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight or Obese Adults
- What is being tested?
- High Fiber bar with Inulin and Low fiber bar - no inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 to 65 years of age, inclusive. There will be approximately equal numbers of men and women.
- Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
- Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 days per cycle) for at least 3 months prior to visit 1.
- 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.
Who cannot join
- 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.
- Individual habitually consumes fiber supplements. A 14-day washout prior to the first test and throughout the study period is permitted.
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
- Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to visit 1 and the participant must be willing to refrain from use during the study.
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- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Individual has used an alpha-blocker, beta-blocker, or high-dose diuretic within 30 days of visit 1. Unstable use (initiation or change in dose) within 30 days of visit 1 of other antihypertensive medications is also exclusionary.
- Unstable use (initiation or change in dose) within 30 days of visit 1 of thyroid hormone replacement medications.
- Unstable use (initiation or change in dose) within 30 days of visit 1 of sex hormones. Multiphasic hormonal contraceptives in which the amount of sex hormone in the active pill varies by week (i.e., biphasic, triphasic, quadriphasic) are considered unstable doses of sex hormones and are exclusionary.
- Use of medications or supplements that may influence carbohydrate or fat metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) or ≥1500 µg/day (topical, inhaled, intranasal, or dermal) corticosteroids within 30 days of visit 1.
- Use of any weight loss medication within 90 days of visit 1.
- Use of medications or supplements that may influence heart rate, including but not limited to stimulant medications (e.g., amphetamines, methylphenidates, etc.) within 30 days of visit 1.
- Use of digestive enzymes, prebiotics, probiotics, and/or postbiotics within 14 days of the first test visit and throughout the study period.
- Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- Individual has had a weight change of ± 4.5 kg (10 lb.) in the previous 3 months.
- Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian).
- Individual is actively following a weight loss diet (even if maintaining body weight).
- Individual has a history of bariatric surgery or is actively attempting to lose or gain body weight.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- History of any major trauma or major surgical event within 2 months of visit 1.
- Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
- Individual has an allergy, sensitivity or intolerance to any components of the study product or study meals.
- Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Individual has been exposed to any non-registered drug product within 30 days prior to screening.
- Individual has a current or recent history (within 12 months prior to screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1.5 oz. hard liquor).
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Crossover Trial to Assess the Effects of Short-term Diets With and Without Inulin on Energy Expenditure in Adults
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.
- Conditions
- Healthy, Overweight or Obese Adults
- Being tested
- High Fiber bar with Inulin, Low fiber bar - no inulin
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fiber bar with InulinOther
Bar with inulin - high fiber
Low fiber bar - no inulinOther
Bar without inulin - low fiber
| Study group | Role | What they receive |
|---|---|---|
| Inulin - high fiber | Experimental | Not described Receives: Other: High Fiber bar with Inulin |
| Control - Low Fiber | Active comparator | Not described Receives: Other: Low fiber bar - no inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure
Measured in kcal/day
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Secondary outcomes (17)
Diet Induced Thermogenesis
Assessed as the AUC and niAUC during the full test period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Diet Induced Thermogenesis
Assessed as the AUC and niAUC during the breakfast period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Diet Induced Thermogenesis
Assessed as the AUC and niAUC during the lunch period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Assessed as the AUC and niAUC during the full test period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Assessed as the AUC and niAUC during the breakfast period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Assessed as the AUC and niAUC during the lunch period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Assessed as the AUC and niAUC during the full test period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Assessed as the AUC and niAUC during the breakfast period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Assessed as the AUC and niAUC during the lunch period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Assessed as the AUC and niAUC during the full test period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Assessed as the AUC and niAUC during the breakfast period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Assessed as the AUC and niAUC during the lunch period
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Fasting Carbohydrate Oxidation
Assessed from pre-consumption
Measured: pre-consumption
Fasting Fat Oxidation
Assessed from pre-consumption
Measured: pre-consumption
Fasting RER
Assessed from pre-consumption
Measured: pre-consumption
Fat Mass
Measured using the Styku body scanner.
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Fat-Free Mass
Calculated by subtracting fat mass from body mass.
Measured: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start7 Apr 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923332
- Sponsor's protocol ID
- MB-2430
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Trial to Assess the Effects of Short-term Diets With and Without Inulin on Energy Expenditure in Adults
- ClinicalTrials.gov ID
- NCT06923332
- Acronym / sponsor ID
- MB-2430
- Conditions
- Healthy, Overweight or Obese Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 11 Apr 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inulin - high fiber | Experimental | Other: High Fiber bar with Inulin |
| Control - Low Fiber | Active comparator | Other: Low fiber bar - no inulin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 to 65 years of age, inclusive. There will be approximately equal numbers of men and women.
- Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
- Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 days per cycle) for at least 3 months prior to visit 1.
- 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.
Key exclusion criteria (27 listed)
- 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.
- Individual habitually consumes fiber supplements. A 14-day washout prior to the first test and throughout the study period is permitted.
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
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 |
|---|---|---|
| High Fiber bar with InulinBar with inulin - high fiber | Other | Inulin - high fiber |
| Low fiber bar - no inulinBar without inulin - low fiber | Other | Control - Low Fiber |
Primary outcome
Resting Energy Expenditure
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Measured in kcal/day
17 secondary outcomes
Diet Induced Thermogenesis
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Diet Induced Thermogenesis
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Diet Induced Thermogenesis
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial carbohydrate oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial fat oxidation rate
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Postprandial respiratory exchange ration (RER)
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Fasting Carbohydrate Oxidation
Time frame: pre-consumption
Fasting Fat Oxidation
Time frame: pre-consumption
Fasting RER
Time frame: pre-consumption
Fat Mass
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Fat-Free Mass
Time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kevin C Maki, PhD study director
Midwest Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fiber bar with Inulin and Low fiber bar - no inulin in people with Healthy and Overweight or Obese Adults, run by Midwest Center for Metabolic and Cardiovascular Research 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 6 inclusion and 27 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (time frame: Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.