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OpenTrials
Completed

NCT Number: NCT00889993

Satiety Response After Mixed Fiber Doses

People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.

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Key information

Conditions

Satiety

Age range

18 year–65 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

  • English speaking
  • healthy men and women
  • 18 and 65 years of age
  • non-smoking
  • not taking medications
  • non-dieting (weight stable over last 3 months)
  • BMI between 18 and 27
  • able to give blood through an IV

Exclusion criteria

  • irregular or erratic breakfast eating patterns
  • food allergies to ingredients commonly found in muffins or pizza
  • distaste for muffins or pizza
  • BMI less than 18 or greater than 27
  • weight change > 5 kg in last 3 months (intentional or unintentional)
  • cardiovascular disease
  • diabetes mellitus (fasting blood sugar > 126 mg/dl)
  • cancer in prior 5 years (except basal cell carcinoma of skin)
  • renal or hepatic disease
  • Crohns disease
  • ulcerative colitis
  • any other gastrointestinal conditions that may affect digestion or absorption
  • recent bacterial infection (< 3 months)
  • chronic medication use
  • history of drug or alcohol abuse in prior 6 months
  • concurrent or recent intervention study participation
  • vegetarians
  • people who ate more than approximately 15 g of fiber per day
  • pregnant or lactating women
  • women with irregular menstrual cycles

Treatment and study plan

Mixed Fiber Supplement

Dietary Supplement

Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).

Primary outcomes

  1. Satiety and Food Intake

    Time frame: November 2007 thru May 2008

Secondary outcomes

  1. Glucose, Insulin, Gut Hormone Response

    Time frame: November 2007 thru October 2008

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2009
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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