Satiety Response of Four Dietary Fibers

Study Overview
=================
Brief Summary
-----------------
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine. The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.

Official Title
-----------------
Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Control
* Dietary Supplement: Soluble corn fiber
* Dietary Supplement: Resistant starch
* Dietary Supplement: Fructooligosaccharide
* Dietary Supplement: Inulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women Age 18-40 years Nonsmoking Not taking weight loss medications Non-dieting (weight has not changed more than 11 pounds over three months) BMI between 18.5 and 29 Spoken and written English literacy Exclusion Criteria: Do not regularly consume breakfast Food allergies to wheat, soy, peanut, or dairy BMI less than 25 or greater than 29 upon admission to study Cancer diagnosis in past 5 years History of heart disease, kidney disease, diabetes, or eating disorder History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition History of drug or alcohol abuse in past 6 months Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication Concurrent or recent (within 30 days) intervention study participation Pregnant or lactating Irregular menstrual cycle Vegetarians People who eat more than approximately 15 grams of fiber per day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low fiber control<br>no treatment dinner bar, no treatment breakfast bar | Dietary Supplement: Control<br>* Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.<br>* Other names: Low fiber control;|
| Experimental: Promitor soluble corn fiber<br>12g in dinner bar, 11g in breakfast bar | Dietary Supplement: Soluble corn fiber<br>* Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.<br>* Other names: Promitor soluble corn fiber;|
| Experimental: FiberSym resistant starch<br>12g in dinner bar, 11g breakfast bar | Dietary Supplement: Resistant starch<br>* Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.<br>* Other names: FiberSym resistant starch;|
| Experimental: Orafti P95 fructooligosaccharide<br>12g in dinner bar, 11g in breakfast bar | Dietary Supplement: Fructooligosaccharide<br>* Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.<br>* Other names: Orafti P95 fructooligosaccharide;|
| Experimental: Orafti HPX inulin<br>12g in dinner bar, 11g in breakfast bar | Dietary Supplement: Inulin<br>* Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.<br>* Other names: Orafti HPX inulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety response using visual analogue scales | Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake |  | 180 minutes postprandially and over 24 hours | 
| Breath hydrogen response |  | 0 and 180 minutes | 
| Gastrointestinal tolerance using visual analogue scales (VAS) | Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Women, Dietary Fiber, Satiety Response, Food Intake