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OpenTrials
Completed

NCT Number: NCT00958399

Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota - General Clinical Research Center

Minneapolis, Minnesota, 55455, 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 18-60 years
  • non-smoking
  • not taking medication
  • non-dieting (weight stable in prior 3 months)
  • BMI 18-27
  • English literacy
  • ability to give blood

Exclusion criteria

  • do not regularly consume breakfast
  • food allergies to ingredients found in study products
  • dislike for muffins, fiber bars, or hot cereal
  • BMI <18 or >27
  • diagnosed cardiovascular, renal, or hepatic disease
  • diabetes mellitus (fasting blood sugar >126 mg/dl)
  • cancer in previous 5 years (except basal cell carcinoma of the skin)
  • any gastrointestinal disease or condition
  • recent bacterial infection (< 3 months)
  • 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
  • restrained eaters
  • 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

Dietary Supplement

Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Resistant starch

Dietary Supplement

25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Resistant starch + soluble fiber

Dietary Supplement

25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Fiber made from corn starch

Dietary Supplement

25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Fiber made from corn starch + soluble fiber

Dietary Supplement

25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Primary outcomes

  1. Satiety

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially

Secondary outcomes

  1. ad libitum food intake

    Time frame: 180 minutes postprandially and over 24 hours

  2. Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response

    Time frame: 0, 30, 60 minutes postprandially

  3. Gastrointestinal tolerance and fecal chemistry

    Time frame: following 7 days of treatment

  4. Glucose/Insulin Response

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Tate and Lyle Ingredients France

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 13, 2009
Registry last updated
Feb 6, 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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