Resistant Starch and Satiety

Satiety Response of Resistant Starches

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 29, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: satiety, dietary fiber
• Other Study ID Numbers: 806M37445