Fibersol-2 Clinical Trials Related to Appetite

February 25, 2011 updated by: Iowa State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Ames, Iowa, United States, 50011
        • Nutrition and Wellness Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • Fibersol-2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analog scale questionnaire subjective satiety responses
Time Frame: 4 hours
Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)
4 hours
serum cholecystokinin (CCK)
Time Frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
4 hours
serum peptide YY (PYY)
Time Frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
4 hours
serum glucagon-like peptide-1 (GLP-1)
Time Frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
4 hours
serum ghrelin
Time Frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
4 hours
serum gastric inhibitory peptide (GIP)
Time Frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
serum total cholesterol
Time Frame: 4 hours
0, 30, 60, 120, 180, 240 min
4 hours
serum LDL-cholesterol
Time Frame: 4 hours
0, 30, 60, 120, 180, 240 min
4 hours
serum HDL-cholesterol
Time Frame: 4 hours
0, 30, 60, 120, 180, 240 min
4 hours
serum triglycerides
Time Frame: 4 hours
0, 30, 60, 120, 180, 240 min
4 hours
serum free fatty acids
Time Frame: 4 hours
0, 30, 60, 120, 180, 240 min
4 hours
serum glucose
Time Frame: 2 hours
0, 30, 60, 90, 120 min
2 hours
serum insulin
Time Frame: 2 hours
0, 30, 60, 90, 120 min
2 hours
gastrointestinal symptoms questionnaire
Time Frame: 24 h
subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iowa State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Archer Daniels Midland Co.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzanne Hendrich, PhD, Iowa State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADM FB2-1 Hendrich
  • 08-291 (Other Identifier: ISU IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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