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Completed

NCT Number: NCT01187875

Resistant Starch and Satiety

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo- Fiber free control

Dietary Supplement

Dextrin control administered in a muffin treatment.

Hi-maize resistant starch 9g

Dietary Supplement

9g Hi-maize resistant starch administered in a muffin treatment.

Novalose 330 resistant starch 9g

Dietary Supplement

9g Novalose 330 resistant starch administered in a muffin treatment.

4.5g Hi-maize resistant starch and 4.5g Novalose 330

Dietary Supplement

4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Satiety Response of Resistant Starches

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 24, 2010
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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