Fibersol-2 Clinical Trials Related to Appetite

Iowa State University

Status: Completed

Conditions: Lack of Satiety

Treatments: Dietary Supplement: digestion-resistant maltodextrin; Other: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01305291

ADM FB2-1 Hendrich

08-291 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 5 patient groups, including a placebo group

tea only without fibersol-2

Placebo Comparator group

Description:

* 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.

Treatment:

Other: placebo

tea only with fibersol-2 (10 g)

Active Comparator group

Description:

* 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.

Treatment:

Dietary Supplement: digestion-resistant maltodextrin

tea without fibersol-2 and meal

Placebo Comparator group

Description:

* 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.

Treatment:

Other: placebo

tea with 5 g fibersol-2 and meal

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: digestion-resistant maltodextrin

tea with 10 g fibersol-2 and meal

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: digestion-resistant maltodextrin