Resistant Starch and Satiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01187875
First received: June 21, 2010
Last updated: March 28, 2012
Last verified: March 2012

June 21, 2010
March 28, 2012
September 2009
June 2010   (final data collection date for primary outcome measure)
  • Satiety response using visual analogue scales [ Time Frame: 0 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 45 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 120 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 minutes postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: 240 minutes postprandially ] [ Designated as safety issue: No ]
    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 visual analogue scales [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially ] [ Designated as safety issue: No ]
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Complete list of historical versions of study NCT01187875 on ClinicalTrials.gov Archive Site
  • Ad libitum food intake [ Time Frame: 240 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
  • Breath hydrogen response [ Time Frame: 0, 240 minutes ] [ Designated as safety issue: No ]
  • Gastrointestinal tolerance using visual analogue scales (VAS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Adults
  • Dietary Supplement: Placebo- Fiber free control
    Dextrin control administered in a muffin treatment.
  • Dietary Supplement: Hi-maize resistant starch 9g
    9g Hi-maize resistant starch administered in a muffin treatment.
  • Dietary Supplement: Novalose 330 resistant starch 9g
    9g Novalose 330 resistant starch administered in a muffin treatment.
  • 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.
  • Placebo Comparator: Control
    Dextrin Control
    Intervention: Dietary Supplement: Placebo- Fiber free control
  • Experimental: Hi-maize resistant starch 9g
    Hi-maize resistant starch 9g
    Intervention: Dietary Supplement: Hi-maize resistant starch 9g
  • Experimental: Novalose 330 resistant starch 9g
    Novalose 330 resistant starch 9g
    Intervention: Dietary Supplement: Novalose 330 resistant starch 9g
  • Experimental: 4.5g Hi-maize and 4.5g Novalose 330
    4.5g Hi-maize and 4.5g Novalose 330
    Intervention: Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01187875
806M37445
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP