Fiber's Utilization for Energy and Life

Study Overview
=================
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.

Official Title
-----------------
Fiber's Utilization for Energy and Life

Conditions
-----------------
Diet Habit

Intervention / Treatment
-----------------
* Other: Fiber
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiber, Metabolizable Energy, Gastrointestinal Microbiota