Fiber's Utilization for Energy and Life

Diet Habit Clinical Trial

— FUEL  

Official title:

Fiber's Utilization for Energy and Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05934357
• Other study ID #: 24042
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit

Intervention

Other:
• Fiber
The intervention treatment will contain fiber.
• Control
The control treatment will contain corn meal.

Locations

Country	Name	City	State
United States	Edward R Madigan Laboratory	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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)