Lack of SatietyNCT01305291

Fibersol-2 Clinical Trials Related to Appetite

A study testing digestion-resistant maltodextrin in people with Lack of Satiety, run by Iowa State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for: Lack of Satiety
What is being tested?: digestion-resistant maltodextrin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Nov 2009
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 62 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

No known food allergies
Normal healthy individuals
No food intake abnormalities or abnormal feeding behaviors
Average American BMI (21-28)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nutrition and Wellness Research Center
Ames, Iowa, 50011

Other trials in United States

About this study

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.

Conditions: Lack of Satiety
Being tested: placebo, digestion-resistant maltodextrin
Keywords: dietary fiber, satiety response, hunger, CCK, PYY, ghrelin, GIP, GLP-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboOther
digestion-resistant maltodextrinDietary supplement
Also called Fibersol-2

Study groups in NCT01305291
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: digestion-resistant maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual analog scale questionnaire subjective satiety responses
Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)
Measured: 4 hours
serum cholecystokinin (CCK)
0, 30, 60, 120, 180, and 240 min post-meal
Measured: 4 hours
serum peptide YY (PYY)
0, 30, 60, 120, 180, and 240 min post-meal
Measured: 4 hours
serum glucagon-like peptide-1 (GLP-1)
0, 30, 60, 120, 180, and 240 min post-meal
Measured: 4 hours
serum ghrelin
0, 30, 60, 120, 180, and 240 min post-meal
Measured: 4 hours
serum gastric inhibitory peptide (GIP)
0, 30, 60, 120, 180, and 240 min post-meal
Measured: 4 hours

Secondary outcomes (8)

serum total cholesterol
0, 30, 60, 120, 180, 240 min
Measured: 4 hours
serum LDL-cholesterol
0, 30, 60, 120, 180, 240 min
Measured: 4 hours
serum HDL-cholesterol
0, 30, 60, 120, 180, 240 min
Measured: 4 hours
serum triglycerides
0, 30, 60, 120, 180, 240 min
Measured: 4 hours
serum free fatty acids
0, 30, 60, 120, 180, 240 min
Measured: 4 hours
serum glucose
0, 30, 60, 90, 120 min
Measured: 2 hours
serum insulin
0, 30, 60, 90, 120 min
Measured: 2 hours
gastrointestinal symptoms questionnaire
subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h
Measured: 24 h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2009

First posted28 Feb 2011 (estimated)
Study startNov 2008
Primary completionJul 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lack of SatietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01305291
Sponsor's protocol ID: ADM FB2-1 Hendrich
Other IDs: 08-291
Status last verified: Feb 2011
First submitted: 25 Feb 2011
Last updated: 28 Feb 2011
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 25823991

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fibersol-2 Clinical Trials Related to Appetite
ClinicalTrials.gov ID: NCT01305291
Acronym / sponsor ID: ADM FB2-1 Hendrich
Conditions: Lack of Satiety
Keywords: dietary fiber, satiety response, hunger, CCK, PYY, ghrelin, GIP, GLP-1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Iowa State UniversityUniversity, hospital or other
Collaborators: Archer Daniels Midland Co.
Study start: Nov 2008
Primary completion: Jul 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 28 Feb 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
tea only without fibersol-2	Placebo comparator	Other: placebo* 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.
tea only with fibersol-2 (10 g)	Active comparator	Dietary Supplement: digestion-resistant maltodextrin* 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.
tea without fibersol-2 and meal	Placebo comparator	Other: placebo* 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.
tea with 5 g fibersol-2 and meal	Experimental	Dietary Supplement: digestion-resistant maltodextrin* 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.
tea with 10 g fibersol-2 and meal	Experimental	Dietary Supplement: digestion-resistant maltodextrin* 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.

Who may qualify

Ages: 18 to 62 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

No known food allergies
Normal healthy individuals
No food intake abnormalities or abnormal feeding behaviors
Average American BMI (21-28)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebo	Other	tea only without fibersol-2, tea without fibersol-2 and meal
digestion-resistant maltodextrinAlso: Fibersol-2	Dietary supplement	tea only with fibersol-2 (10 g), tea with 10 g fibersol-2 and meal, tea with 5 g fibersol-2 and meal

Primary outcome

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)
serum cholecystokinin (CCK)
Time frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
serum peptide YY (PYY)
Time frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
serum glucagon-like peptide-1 (GLP-1)
Time frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
serum ghrelin
Time frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal
serum gastric inhibitory peptide (GIP)
Time frame: 4 hours
0, 30, 60, 120, 180, and 240 min post-meal

8 secondary outcomes

serum total cholesterol
Time frame: 4 hours
serum LDL-cholesterol
Time frame: 4 hours
serum HDL-cholesterol
Time frame: 4 hours
serum triglycerides
Time frame: 4 hours
serum free fatty acids
Time frame: 4 hours
serum glucose
Time frame: 2 hours
serum insulin
Time frame: 2 hours
gastrointestinal symptoms questionnaire
Time frame: 24 h

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
Derived from this study: PubMed 25823991Ye 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suzanne Hendrich, PhD principal investigator

Iowa State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing digestion-resistant maltodextrin in people with Lack of Satiety, run by Iowa State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale questionnaire subjective satiety responses (time frame: 4 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01305291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2011.