Fibersol-2 Clinical Trials Related to Appetite

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

Tracking Information

• First Submitted Date: February 25, 2011
• First Posted Date: February 28, 2011
• Last Update Posted Date: February 28, 2011
• Study Start Date: November 2008
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fibersol-2 Clinical Trials Related to Appetite
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Lack of Satiety

Intervention

• Other: placebo
• Dietary Supplement: digestion-resistant maltodextrin
  Other Name: Fibersol-2

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2011): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 62 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01305291
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Suzanne Hendrich, Iowa State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Iowa State University
• Original Study Sponsor: Same as current
• Collaborators: Archer Daniels Midland Co.

Investigators

• Principal Investigator: Suzanne Hendrich, PhD; Iowa State University

• PRS Account: Iowa State University
• Verification Date: February 2011