MedPath

Fiber's Utilization for Energy and Life

Not Applicable
Active, not recruiting
Conditions
Diet Habit
Interventions
Other: Fiber
Other: Control
Registration Number
NCT05934357
Lead Sponsor
University of Illinois at Urbana-Champaign
Brief Summary

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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
19
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Intervention TreatmentFiberExperimental treatment will contain a cereal product that contains a dietary fiber. This will be consumed three times daily for two weeks.
Control treatmentControlControl treatment will contain a corn meal cereal product that will be consumed three times daily for two weeks.
Primary Outcome Measures
NameTimeMethod
Metabolizable Energy of the Dietduring the last 5 days of the 2 week intervention period

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.

Secondary Outcome Measures
NameTimeMethod
Fecal Microbiotaend of week 2 (end of intervention period)

We will conduct qPCR to quantify total bacterial cells within one fresh fecal sample collected during week 2 of each condition.

Trial Locations

Locations (1)

Edward R Madigan Laboratory

🇺🇸

Urbana, Illinois, United States

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