A Trial to Assess the Effects of Diets With and Without Inulin on Energy Expenditure in Adults.

NCT06923332 | Completed

• 1 other identifier: MB-2430
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Overweight or Obese Adults

Outcome Measures

Primary Outcomes (1)

• Resting Energy Expenditure

  Measured in kcal/day

  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

  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

  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

  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

  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

  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.

Study Arms (2)

Inulin - high fiber

EXPERIMENTAL

Other: High Fiber bar with Inulin

Control - Low Fiber

ACTIVE COMPARATOR

Other: Low fiber bar - no inulin

Interventions

High Fiber bar with Inulin OTHER

Bar with inulin - high fiber

Inulin - high fiber

Low fiber bar - no inulin OTHER

Bar without inulin - low fiber

Control - Low Fiber

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
• Unstable use (initiation or change in dose) within 30 days of visit 1 of thyroid hormone replacement medications.
• 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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• General Mills: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

Inulin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Kevin C Maki, PhD

  MB Clinical Research and Consulting LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 11, 2025
• Study Start: April 7, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)