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
  Purpose

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.


Condition Intervention Phase
Healthy Adults
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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Satiety Response of Resistant Starches

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Dextrin Control
Dietary Supplement: Placebo- Fiber free control
Dextrin control administered in a muffin treatment.
Experimental: Hi-maize resistant starch 9g
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
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187875

Locations
United States, Minnesota
University of Minnesota
Saint Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01187875     History of Changes
Other Study ID Numbers: 806M37445
Study First Received: June 21, 2010
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
satiety, dietary fiber

ClinicalTrials.gov processed this record on April 16, 2014