Fiber's Utilization for Energy and Life

NCT05934357 | Unknown

• 1 other identifier: 24042
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Habit

Keywords

Fiber; Metabolizable Energy; Gastrointestinal Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fecal Microbiota

  end of week 2 (end of intervention period)

Other Outcomes (4)

• Gastrointestinal Tolerance

  daily during the second week of each intervention period

• Bowel Function

  week 2 of each intervention period

• Stool Consistency

  daily during the second week of each intervention period

Study Arms (2)

Intervention Treatment

EXPERIMENTAL

Experimental treatment will contain a cereal product that contains a dietary fiber. This will be consumed three times daily for two weeks.

Other: Fiber

Control treatment

PLACEBO COMPARATOR

Control treatment will contain a corn meal cereal product that will be consumed three times daily for two weeks.

Other: Control

Interventions

Fiber OTHER

The intervention treatment will contain fiber.

Intervention Treatment

Control OTHER

The control treatment will contain corn meal.

Control treatment

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Edward R Madigan Laboratory

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: July 6, 2023
• Study Start: May 13, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)