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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014