Resistant Starch and Satiety

Study Overview
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Brief Summary
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Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.

Official Title
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Satiety Response of Resistant Starches

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: Placebo- Fiber free control
* Dietary Supplement: Hi-maize resistant starch 9g
* Dietary Supplement: Novalose 330 resistant starch 9g
* Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women Age 18-64 years Non-smoking Not taking medication Non dieting (weight stable in prior 3 months) BMI 18-27 English literacy Exclusion Criteria: Do not regularly consume breakfast Food allergies to ingredients found in the study products BMI <18 or >27 Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus Cancer in previous 5 years Any gastrointestinal disease or condition Recent bacterial infection (< 3months) 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 Eating disorder 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: 64 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Dextrin Control | Dietary Supplement: Placebo- Fiber free control<br>* Dextrin control administered in a muffin treatment.<br>|
| Experimental: Hi-maize resistant starch 9g<br>Hi-maize resistant starch 9g | Dietary Supplement: Hi-maize resistant starch 9g<br>* 9g Hi-maize resistant starch administered in a muffin treatment.<br>|
| Experimental: Novalose 330 resistant starch 9g<br>Novalose 330 resistant starch 9g | Dietary Supplement: Novalose 330 resistant starch 9g<br>* 9g Novalose 330 resistant starch administered in a muffin treatment.<br>|
| Experimental: 4.5g Hi-maize and 4.5g Novalose 330<br>4.5g Hi-maize and 4.5g Novalose 330 | Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330<br>* 4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety response using visual analogue scales | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 0 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 15 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 30 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 45 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 60 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 90 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 120 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 180 minutes postprandially | 
| Satiety response using VAS | Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS). | 240 minutes postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum food intake |  | 240 minutes postprandially and over 24 hours | 
| Breath hydrogen response |  | 0, 240 minutes | 
| Gastrointestinal tolerance using visual analogue scales (VAS) | Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satiety, dietary fiber