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History of Changes for Study: NCT01305291
Fibersol-2 Clinical Trials Related to Appetite
Latest version (submitted February 25, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 25, 2011 None (earliest Version on record)
Comparison Format:
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Study NCT01305291
Submitted Date:  February 25, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: ADM FB2-1 Hendrich
Brief Title: Fibersol-2 Clinical Trials Related to Appetite
Official Title: Fibersol-2 Clinical Trials Related to Appetite
Secondary IDs: 08-291 [ISU IRB]
Open or close this module Study Status
Record Verification: February 2011
Overall Status: Completed
Study Start: November 2008
Primary Completion: July 2009 [Actual]
Study Completion: November 2009 [Actual]
First Submitted: February 25, 2011
First Submitted that
Met QC Criteria:		 February 25, 2011
First Posted: February 28, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 February 25, 2011
Last Update Posted: February 28, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Iowa State University
Responsible Party:
Collaborators: Archer Daniels Midland Co.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Lack of Satiety
Keywords: dietary fiber
satiety response
hunger
CCK
PYY
ghrelin
GIP
GLP-1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 5
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 20 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
 Dietary Supplement: digestion-resistant maltodextrin
Other Names:
  • Fibersol-2
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.
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.
 Dietary Supplement: digestion-resistant maltodextrin
Other Names:
  • Fibersol-2
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.
 Dietary Supplement: digestion-resistant maltodextrin
Other Names:
  • Fibersol-2
Open or close this module Outcome Measures
Primary Outcome Measures:
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 Outcome Measures:
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 62 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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)
Open or close this module Contacts/Locations
Study Officials: Suzanne Hendrich, PhD
Principal Investigator
Iowa State University
Locations: United States, Iowa
Nutrition and Wellness Research Center
Ames, Iowa, United States, 50011
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services