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Fibersol-2 Clinical Trials Related to Appetite

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ClinicalTrials.gov Identifier: NCT01305291
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : February 28, 2011
Sponsor:
Collaborator:
Archer Daniels Midland Co.
Information provided by:
Iowa State University

Tracking Information
First Submitted Date  ICMJE February 25, 2011
First Posted Date  ICMJE February 28, 2011
Last Update Posted Date February 28, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
  • 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)
  • serum cholecystokinin (CCK) [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, and 240 min post-meal
  • serum peptide YY (PYY) [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, and 240 min post-meal
  • serum glucagon-like peptide-1 (GLP-1) [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, and 240 min post-meal
  • serum ghrelin [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, and 240 min post-meal
  • serum gastric inhibitory peptide (GIP) [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, and 240 min post-meal
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
  • serum total cholesterol [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, 240 min
  • serum LDL-cholesterol [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, 240 min
  • serum HDL-cholesterol [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, 240 min
  • serum triglycerides [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, 240 min
  • serum free fatty acids [ Time Frame: 4 hours ]
    0, 30, 60, 120, 180, 240 min
  • serum glucose [ Time Frame: 2 hours ]
    0, 30, 60, 90, 120 min
  • serum insulin [ Time Frame: 2 hours ]
    0, 30, 60, 90, 120 min
  • gastrointestinal symptoms questionnaire [ Time Frame: 24 h ]
    subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fibersol-2 Clinical Trials Related to Appetite
Official Title  ICMJE Fibersol-2 Clinical Trials Related to Appetite
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Lack of Satiety
Intervention  ICMJE
  • Other: placebo
  • Dietary Supplement: digestion-resistant maltodextrin
    Other Name: Fibersol-2
Study Arms  ICMJE
  • Placebo Comparator: tea only without fibersol-2
    • On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day.
    • The evening meal will be a standardized meal for all subjects (11).
    • They are allowed to consume water up until 1 hr before the test.
    • Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling (11).
    • The beverage will be consumed at 10 am.
    • Blood samples will be taken at specified time points prior to after the treatments.
    Intervention: Other: placebo
  • Active Comparator: tea only with fibersol-2 (10 g)
    • On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day.
    • The evening meal will be a standardized meal for all subjects.
    • They are allowed to consume water up until 1 hr before the test.
    • Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling (11).
    • The beverage will be consumed at 10 am.
    • Blood samples will be taken at specified time points prior to and after the treatments.
    • Ingredient only test will be done without the meal to determine independent effects of Fibersol-2.
    Intervention: Dietary Supplement: digestion-resistant maltodextrin
  • Placebo Comparator: tea without fibersol-2 and meal
    • On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day.
    • The evening meal will be a standardized meal for all subjects.
    • They are allowed to consume water up until 1 hr before the test.
    • Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling.
    • The test meal and beverage will be consumed at 10 am.
    • The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739).
    • Tea containing test materials will accompany the meal.
    • Blood samples will be taken at specified time points prior to and after the treatments.
    Intervention: Other: placebo
  • Experimental: tea with 5 g fibersol-2 and meal
    • On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day.
    • The evening meal will be a standardized meal for all subjects.
    • They are allowed to consume water up until 1 hr before the test.
    • Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling.
    • The test meal and beverage will be consumed at 10 am.
    • The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739).
    • Tea containing test materials will accompany the meal.
    • Blood samples will be taken at specified time points prior to and after the treatments.
    Intervention: Dietary Supplement: digestion-resistant maltodextrin
  • Experimental: tea with 10 g fibersol-2 and meal
    • On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day.
    • The evening meal will be a standardized meal for all subjects.
    • They are allowed to consume water up until 1 hr before the test.
    • Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling.
    • The test meal and beverage will be consumed at 10 am.
    • The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739).
    • Tea containing test materials will accompany the meal.
    • Blood samples will be taken at specified time points prior to and after the treatments.
    Intervention: Dietary Supplement: digestion-resistant maltodextrin
Publications * Ye Z, Arumugam V, Haugabrooks E, Williamson P, Hendrich S. Soluble dietary fiber (Fibersol-2) decreased hunger and increased satiety hormones in humans when ingested with a meal. Nutr Res. 2015 May;35(5):393-400. doi: 10.1016/j.nutres.2015.03.004. Epub 2015 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2011)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01305291
Other Study ID Numbers  ICMJE ADM FB2-1 Hendrich
08-291 ( Other Identifier: ISU IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzanne Hendrich, Iowa State University
Study Sponsor  ICMJE Iowa State University
Collaborators  ICMJE Archer Daniels Midland Co.
Investigators  ICMJE
Principal Investigator: Suzanne Hendrich, PhD Iowa State University
PRS Account Iowa State University
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP