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Resistant Starch and Satiety

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ClinicalTrials.gov Identifier: NCT01187875
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Satiety Response of Resistant Starches
Study Start Date : September 2009
Primary Completion Date : June 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions

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
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.


Outcome Measures

Primary Outcome Measures :
  1. Satiety response using visual analogue scales [ Time Frame: 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).

  2. Satiety response using VAS [ Time Frame: 15 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).

  3. Satiety response using VAS [ Time Frame: 30 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).

  4. Satiety response using VAS [ Time Frame: 45 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).

  5. Satiety response using VAS [ Time Frame: 60 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).

  6. Satiety response using VAS [ Time Frame: 90 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).

  7. Satiety response using VAS [ Time Frame: 120 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).

  8. Satiety response using VAS [ Time Frame: 180 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).

  9. Satiety response using VAS [ Time Frame: 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 :
  1. Ad libitum food intake [ Time Frame: 240 minutes postprandially and over 24 hours ]
  2. Breath hydrogen response [ Time Frame: 0, 240 minutes ]
  3. Gastrointestinal tolerance using visual analogue scales (VAS) [ Time Frame: 24 hours ]
    Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01187875     History of Changes
Other Study ID Numbers: 806M37445
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

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