Fibersol-2 Clinical Trials Related to Appetite

This study has been completed.
Sponsor:
Collaborator:
Archer Daniels Midland Co.
Information provided by:
Iowa State University
ClinicalTrials.gov Identifier:
NCT01305291
First received: February 25, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Lack of Satiety
Other: placebo
Dietary Supplement: digestion-resistant maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Fibersol-2 Clinical Trials Related to Appetite

Resource links provided by NLM:


Further study details as provided by Iowa State University:

Primary Outcome Measures:
  • Visual analog scale questionnaire subjective satiety responses [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)

  • serum cholecystokinin (CCK) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, and 240 min post-meal

  • serum peptide YY (PYY) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, and 240 min post-meal

  • serum glucagon-like peptide-1 (GLP-1) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, and 240 min post-meal

  • serum ghrelin [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, and 240 min post-meal

  • serum gastric inhibitory peptide (GIP) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, and 240 min post-meal


Secondary Outcome Measures:
  • serum total cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, 240 min

  • serum LDL-cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, 240 min

  • serum HDL-cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, 240 min

  • serum triglycerides [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, 240 min

  • serum free fatty acids [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180, 240 min

  • serum glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 90, 120 min

  • serum insulin [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    0, 30, 60, 90, 120 min

  • gastrointestinal symptoms questionnaire [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
    subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h


Enrollment: 20
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.
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.
Dietary Supplement: digestion-resistant maltodextrin
Other Name: 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.
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.
Dietary Supplement: digestion-resistant maltodextrin
Other Name: 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 Name: Fibersol-2

  Eligibility

Ages Eligible for Study:   18 Years to 62 Years
Genders Eligible for Study:   Both
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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305291

Locations
United States, Iowa
Nutrition and Wellness Research Center
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Iowa State University
Archer Daniels Midland Co.
Investigators
Principal Investigator: Suzanne Hendrich, PhD Iowa State University
  More Information

No publications provided

Responsible Party: Suzanne Hendrich, Iowa State University
ClinicalTrials.gov Identifier: NCT01305291     History of Changes
Other Study ID Numbers: ADM FB2-1 Hendrich, 08-291
Study First Received: February 25, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Iowa State University:
dietary fiber
satiety response
hunger
CCK
PYY
ghrelin
GIP
GLP-1

ClinicalTrials.gov processed this record on April 17, 2014