Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Study Overview
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Brief Summary
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Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones. The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.

Official Title
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Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Resistant Starch
* Dietary Supplement: Resistant starch + soluble fiber
* Dietary Supplement: Fiber made from corn starch
* Dietary Supplement: Fiber made from corn starch + soluble fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy men and women age 18-60 years non-smoking not taking medication non-dieting (weight stable in prior 3 months) BMI 18-27 English literacy ability to give blood Exclusion Criteria: do not regularly consume breakfast food allergies to ingredients found in study products dislike for muffins, fiber bars, or hot cereal BMI <18 or >27 diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus (fasting blood sugar >126 mg/dl) cancer in previous 5 years (except basal cell carcinoma of the skin) any gastrointestinal disease or condition recent bacterial infection (< 3 months) recent or concurrent participation in an intervention research study history of drug or alcohol abuse in prior 6 months use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication restrained eaters vegetarians people who eat more than approximately 15 grams of fiber per day women who are pregnant or lactating women with irregular menstrual cycles

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No fiber<br>No fiber added to study products | Dietary Supplement: Placebo<br>* Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)<br>|
| Experimental: Resistant Starch<br>Muffins, cereal, and bars made with a resistant starch | Dietary Supplement: Resistant Starch<br>* 25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)<br>|
| Experimental: Resistant starch + soluble fiber<br>Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber | Dietary Supplement: Resistant starch + soluble fiber<br>* 25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)<br>|
| Experimental: Fiber made from corn starch<br>Muffins, cereal, and bars made with novel corn fiber | Dietary Supplement: Fiber made from corn starch<br>* 25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)<br>|
| Experimental: Fiber made from corn starch + soluble fiber<br>Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber | Dietary Supplement: Fiber made from corn starch + soluble fiber<br>* 25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety |  | 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ad libitum food intake |  | 180 minutes postprandially and over 24 hours | 
| Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response |  | 0, 30, 60 minutes postprandially | 
| Gastrointestinal tolerance and fecal chemistry |  | following 7 days of treatment | 
| Glucose/Insulin Response |  | 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satiety, fiber, food intake, gut hormones, visual analog scales, microflora