Assessing Fermentability of a Dietary Fiber

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days.

Detailed Description
-----------------
This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour postprandial crossover study, utilizing a multiple sampling paradigm to evaluate fermentability and potential health opportunities for glucose control of a dietary fiber (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments following consumption of the FCHO drink or a placebo drink and will follow with a 7 day feeding period to assess tolerability.

Official Title
-----------------
Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women

Conditions
-----------------
Nutritional Intervention

Intervention / Treatment
-----------------
* Dietary Supplement: A dietary fiber (FCHO)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older BMI between 18.5 and 29.9 kg/m2, inclusive No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease No diabetes No Gastrointestinal issues Exclusion Criteria: Pregnant and/or lactating or planning for pregnancy Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125 mg/dL. Vegetarian Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints Taking actively probiotics or purposely taking/ subscribing to a diet high in prebiotics. Taking prescription medications that may interfere with study procedures or endpoints (eg., antibiotics) Subjects with unusual dietary habits (e.g. pica) Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period) Excessive exercisers or trained athletes Addicted to drugs and/or alcohol Medically documented psychiatric or neurological disturbances Smokers (past smokers may be allowed if cessation is > 2 years)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Beverage | Dietary Supplement: Placebo<br>* Placebo drink<br>* Other names: PCB;|
| Active Comparator: A dietary fiber (FCHO)<br>15g/BID | Dietary Supplement: A dietary fiber (FCHO)<br>* 15 g twice per day in beverage<br>* Other names: FCHO;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women | FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr. | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink | FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Blood glucose will be measured before (fasting/baseline) and after breakfast test meal intake for 4hrs: 0, 30 min, 60 min, 120 min, and 240 min and then again after the light lunch meal at 30, 60, 90, 120 post lunch. | 8 hours | 
| The tolerability of treatments over 7 days | After the in-lab study day (visit 1 and visit 2), subjects will go home with the test beverage packs to be consumed daily for 7 days. Subjects will maintain diaries to ensure daily consumption and on day 7 will be asked to complete a brief questionnaire related to gastrointestinal experiences during the week. Identical procedures will take place after both study days, except the assigned treatment will differ. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Fiber, Blood glucose control, Fermentability, Tolerability