NCT01305291

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
Last Updated

February 28, 2011

Status Verified

February 1, 2011

Enrollment Period

8 months

First QC Date

February 25, 2011

Last Update Submit

February 25, 2011

Conditions

Lack of Satiety

Keywords

dietary fibersatiety responsehungerCCKPYYghrelinGIPGLP-1

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (8)

  • serum total cholesterol

    4 hours

  • serum LDL-cholesterol

    4 hours

  • serum HDL-cholesterol

    4 hours

  • serum triglycerides

    4 hours

  • serum free fatty acids

    4 hours

  • +3 more secondary outcomes

Study Arms (5)

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.

Other: placebo

tea with 5 g fibersol-2 and meal

EXPERIMENTAL

* 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

tea with 10 g fibersol-2 and meal

EXPERIMENTAL

* 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

Interventions

placeboOTHER
tea only without fibersol-2tea without fibersol-2 and meal
digestion-resistant maltodextrinDIETARY_SUPPLEMENT
Also known as: Fibersol-2
tea only with fibersol-2 (10 g)tea with 10 g fibersol-2 and mealtea with 5 g fibersol-2 and meal

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • i. No known food allergies
  • ii. Normal healthy individuals
  • iii. No food intake abnormalities or abnormal feeding behaviors
  • iv. Average American BMI (21-28)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Wellness Research Center

Ames, Iowa, 50011, United States

Location

Related Publications (1)

  • 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.

    PMID: 25823991DERIVED

Study Officials

  • Suzanne Hendrich, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

February 28, 2011

Record last verified: 2011-02

Locations

US(1)