Fiber's Utilization for Energy and Life (FUEL)

The study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine.

Study Overview

• Status: Active, not recruiting
• Conditions: Diet Habit
• Intervention / Treatment: Other: Fiber; Other: Control

Detailed Description

The study will be a randomized, crossover, controlled feeding trial comprised of 2 experimental periods: 1) control and 2) fiber. Each experimental condition will be 16 days in length. There will be at least a 12-day compliance break between each period. Participants will undergo complete urine and fecal collection for a period five to seven days during the second half of each experimental condition.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Edward R Madigan Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ages 22-75 years
• BMI between 18.5 and 39.9 kg/m2
• Ability to drop-off 1 fecal sample within 15 minutes of defecation
• Ability to pick-up meals daily
• Ability to collect fecal and urine samples daily
• Fasting glucose of <126 mg/dL

Exclusion Criteria:

• Wheat allergy or intolerance
• Any food allergies or intolerances
• Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
• Women that are pregnant, had a baby within the last 12 months, or are lactating.
• Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
• >5% weight change in the past month or >10% change in the past year
• Oral antibiotics during the previous 6 weeks
• History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery
• Are unable or unwilling to consume the experimental meals/snacks.
• Taking certain medications (Orlistat, bile binding resins, insulin, oral hypoglycemic agents, laxatives)
• Concurrent enrollment in another dietary, exercise, or medication study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Treatment; Experimental treatment will contain a cereal product that contains a dietary fiber. This will be consumed three times daily for two weeks.	Other: Fiber; The intervention treatment will contain fiber.
Placebo Comparator: Control treatment; Control treatment will contain a corn meal cereal product that will be consumed three times daily for two weeks.	Other: Control; The control treatment will contain corn meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolizable Energy of the Diet	The diets provided to participants will be analyzed for their energy and proximate analysis. Fecal and urine samples will be collected for 5 days during week 2 of each intervention period to calculate the total metabolizable energy of the diet. Energy and proximate analysis (dry matter, organic matter, crude protein, acid-hydrolyzed fat, and total dietary fiber) will be analyzed from the provided diet and the fecal samples. Energy will be analyzed from urine samples. The metabolizable energy content will be calculated according to the methods of Novotny et al. (2012), which considers the energy of the diet compared to the remaining energy in the collected fecal and urine samples.	during the last 5 days of the 2 week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Microbiota	We will conduct qPCR to quantify total bacterial cells within one fresh fecal sample collected during week 2 of each condition.	end of week 2 (end of intervention period)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	Participants will indicate if tolerance symptoms (burping, cramping/pain, distension/bloating, flatulence/gas, nausea, reflux, rumblings) are absent, mild, moderate, or severe during the second week of each intervention period. All measures will be assessed using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)	daily during the second week of each intervention period
Bowel Function	Participants will indicate number (how many) and time of bowel movements during week 2 of each intervention condition.	week 2 of each intervention period
Stool Consistency	Participants will use the Bristol Stool Scale during week 2 of each intervention condition to indicate their stool consistency.	daily during the second week of each intervention period
Ease of Passage	Participants will indicate the ease of passage of each bowel movement during week 2 of each intervention condition. The 0-5 scale ranges from 1 (very easy) to 5 (very difficult).	daily during the second week of each intervention period

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Fiber; Gastrointestinal Microbiota; Metabolizable Energy
• Other Study ID Numbers: 24042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No