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Completed

NCT Number: NCT01305291

Fibersol-2 Clinical Trials Related to Appetite

Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut.

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Key information

Conditions

Lack of Satiety

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Wellness Research Center

Ames, Iowa, 50011, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

i. No known food allergies

ii. Normal healthy individuals

iii. No food intake abnormalities or abnormal feeding behaviors

iv. Average American BMI (21-28)

Treatment and study plan

Placebo

Other

digestion-resistant maltodextrin

Dietary Supplement

Other names: Fibersol-2

Primary outcomes

  1. Visual analog scale questionnaire subjective satiety responses

    Time frame: 4 hours

    Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)

  2. serum cholecystokinin (CCK)

    Time frame: 4 hours

    0, 30, 60, 120, 180, and 240 min post-meal

  3. serum peptide YY (PYY)

    Time frame: 4 hours

    0, 30, 60, 120, 180, and 240 min post-meal

  4. serum glucagon-like peptide-1 (GLP-1)

    Time frame: 4 hours

    0, 30, 60, 120, 180, and 240 min post-meal

  5. serum ghrelin

    Time frame: 4 hours

    0, 30, 60, 120, 180, and 240 min post-meal

  6. serum gastric inhibitory peptide (GIP)

    Time frame: 4 hours

    0, 30, 60, 120, 180, and 240 min post-meal

Secondary outcomes

  1. serum total cholesterol

    Time frame: 4 hours

    0, 30, 60, 120, 180, 240 min

  2. serum LDL-cholesterol

    Time frame: 4 hours

    0, 30, 60, 120, 180, 240 min

  3. serum HDL-cholesterol

    Time frame: 4 hours

    0, 30, 60, 120, 180, 240 min

  4. serum triglycerides

    Time frame: 4 hours

    0, 30, 60, 120, 180, 240 min

  5. serum free fatty acids

    Time frame: 4 hours

    0, 30, 60, 120, 180, 240 min

  6. serum glucose

    Time frame: 2 hours

    0, 30, 60, 90, 120 min

  7. serum insulin

    Time frame: 2 hours

    0, 30, 60, 90, 120 min

  8. gastrointestinal symptoms questionnaire

    Time frame: 24 h

    subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Collaborators

  • Archer Daniels Midland Co.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 28, 2011
Registry last updated
Feb 28, 2011

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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