Fibersol-2 Clinical Trials Related to Appetite

NCT ID: NCT01305291

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lack of Satiety

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

digestion-resistant maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

digestion-resistant maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

digestion-resistant maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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placebo

Intervention Type OTHER

digestion-resistant maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fibersol-2

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Archer Daniels Midland Co.

INDUSTRY

Sponsor Role collaborator

Iowa State University

OTHER

Sponsor Role lead

Responsible Party

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Iowa State University

Principal Investigators

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Suzanne Hendrich, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

Locations

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Nutrition and Wellness Research Center

Ames, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25823991 (View on PubMed)

Other Identifiers

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08-291

Identifier Type: OTHER

Identifier Source: secondary_id

ADM FB2-1 Hendrich

Identifier Type: -

Identifier Source: org_study_id