Resistant Starch and Satiety

Early Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: 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

• Registration Number: NCT01187875
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Placebo- Fiber free control	Dextrin Control
Hi-maize resistant starch 9g	Hi-maize resistant starch 9g	Hi-maize resistant starch 9g
Novalose 330 resistant starch 9g	Novalose 330 resistant starch 9g	Novalose 330 resistant starch 9g
4.5g Hi-maize and 4.5g Novalose 330	4.5g Hi-maize resistant starch and 4.5g Novalose 330	4.5g Hi-maize and 4.5g Novalose 330

Primary Outcome Measures

Name	Time	Method
Satiety response using visual analogue scales	0 minutes postprandially	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS	240 minutes postprandially	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Saint Paul, Minnesota, United States