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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014