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

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.

Condition or disease	Intervention/treatment	Phase
Lack of Satiety	Other: placebo; Dietary Supplement: digestion-resistant maltodextrin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Fibersol-2 Clinical Trials Related to Appetite
• Study Start Date: November 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
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

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 62 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Suzanne Hendrich, Iowa State University
• ClinicalTrials.gov Identifier: NCT01305291
• Other Study ID Numbers: ADM FB2-1 Hendrich; 08-291 ( Other Identifier: ISU IRB )
• First Posted: February 28, 2011
• Last Update Posted: February 28, 2011
• Last Verified: February 2011

Keywords provided by Iowa State University:

dietary fiber; satiety response; hunger; CCK; PYY; ghrelin; GIP; GLP-1