Fibersol-2 Clinical Trials Related to Appetite - Full Text View

Sponsor:	Iowa State University
Collaborator:	Archer Daniels Midland Co.
Information provided by:	Iowa State University
ClinicalTrials.gov Identifier:	NCT01305291

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:

MedlinePlus related topics: Diabetes Medicines Dietary Fiber

U.S. FDA Resources

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 May 23, 2012