Fibersol-2 Clinical Trials Related to Appetite | NCT01305291

NCT01305291

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
08-291	Other Identifier	ISU IRB

Status Module

Name	Class
Archer Daniels Midland Co.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tea only without fibersol-2	Placebo Comparator	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
tea only with fibersol-2 (10 g)	Active Comparator	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
tea without fibersol-2 and meal	Placebo Comparator	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.

Name	Type	Description	Arm Group Labels	Other Names
placebo	Other		tea only without fibersol-2 tea without fibersol-2 and meal
digestion-resistant maltodextrin

Outcomes Module

Primary Outcomes

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

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

Eligibility Module

Name	Affiliation	Role
Suzanne Hendrich, PhD	Iowa State University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition and Wellness Research Center		Ames	Iowa	50011	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25823991	Derived	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.