Fibersol-2 Clinical Trials Related to Appetite

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.

Study Overview

• Status: Completed
• Conditions: Lack of Satiety
• Intervention / Treatment: Other: placebo; Dietary supplement: digestion-resistant maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ames, Iowa, United States, 50011
      • Nutrition and Wellness Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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 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.	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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale questionnaire subjective satiety responses	Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)	4 hours
serum cholecystokinin (CCK)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours
serum peptide YY (PYY)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours
serum glucagon-like peptide-1 (GLP-1)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours
serum ghrelin	0, 30, 60, 120, 180, and 240 min post-meal	4 hours
serum gastric inhibitory peptide (GIP)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum total cholesterol	0, 30, 60, 120, 180, 240 min	4 hours
serum LDL-cholesterol	0, 30, 60, 120, 180, 240 min	4 hours
serum HDL-cholesterol	0, 30, 60, 120, 180, 240 min	4 hours
serum triglycerides	0, 30, 60, 120, 180, 240 min	4 hours
serum free fatty acids	0, 30, 60, 120, 180, 240 min	4 hours
serum glucose	0, 30, 60, 90, 120 min	2 hours
serum insulin	0, 30, 60, 90, 120 min	2 hours
gastrointestinal symptoms questionnaire	subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h	24 h

Collaborators and Investigators

• Sponsor: Iowa State University
• Collaborators: Archer Daniels Midland Co.
• Investigators: Principal Investigator: Suzanne Hendrich, PhD, Iowa State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 28, 2011
• Last Update Submitted That Met QC Criteria: February 25, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: GLP-1; ghrelin; hunger; dietary fiber; satiety response; CCK; PYY; GIP
• Other Study ID Numbers: ADM FB2-1 Hendrich; 08-291 (Other Identifier: ISU IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No