SatietyNCT00889993
Satiety Response After Mixed Fiber Doses
A study testing Mixed Fiber Supplement in people with Satiety, run by University of Minnesota at 1 site in United States.
Trial summary
People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety
- What is being tested?
- Mixed Fiber Supplement
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- healthy men and women
- 18 and 65 years of age
- non-smoking
- not taking medications
- non-dieting (weight stable over last 3 months)
- BMI between 18 and 27
- able to give blood through an IV
Who cannot join
- irregular or erratic breakfast eating patterns
- food allergies to ingredients commonly found in muffins or pizza
- distaste for muffins or pizza
- BMI less than 18 or greater than 27
- weight change > 5 kg in last 3 months (intentional or unintentional)
- cardiovascular disease
Show all 20Show fewer
- diabetes mellitus (fasting blood sugar > 126 mg/dl)
- cancer in prior 5 years (except basal cell carcinoma of skin)
- renal or hepatic disease
- Crohns disease
- ulcerative colitis
- any other gastrointestinal conditions that may affect digestion or absorption
- recent bacterial infection (< 3 months)
- chronic medication use
- history of drug or alcohol abuse in prior 6 months
- concurrent or recent intervention study participation
- vegetarians
- people who ate more than approximately 15 g of fiber per day
- pregnant or lactating women
- women with irregular menstrual cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota: General Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Official title: Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release
People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.
The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.
- Conditions
- Satiety
- Being tested
- Mixed Fiber Supplement
- Keywords
- Food intake, Gut hormones, Fiber, Visual analog scales
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Fiber SupplementDietary supplement
Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety and Food Intake
Measured: November 2007 thru May 2008
Secondary outcomes (1)
Glucose, Insulin, Gut Hormone Response
Measured: November 2007 thru October 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
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 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889993
- Sponsor's protocol ID
- 0701M00265
- Status last verified
- Mar 2012
- First submitted
- 27 Apr 2009
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.
PubMed 21310305
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release
- ClinicalTrials.gov ID
- NCT00889993
- Acronym / sponsor ID
- 0701M00265
- Conditions
- Satiety
- Keywords
- Food intake, Gut hormones, Fiber, Visual analog scales
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Apr 2009 (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.
People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.
The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English speaking
- healthy men and women
- 18 and 65 years of age
- non-smoking
- not taking medications
Key exclusion criteria (20 listed)
- irregular or erratic breakfast eating patterns
- food allergies to ingredients commonly found in muffins or pizza
- distaste for muffins or pizza
- BMI less than 18 or greater than 27
- weight change > 5 kg in last 3 months (intentional or unintentional)
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 |
|---|---|---|
| Mixed Fiber SupplementBreakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed). | Dietary supplement | – |
Primary outcome
Satiety and Food Intake
Time frame: November 2007 thru May 2008
1 secondary outcome
Glucose, Insulin, Gut Hormone Response
Time frame: November 2007 thru October 2008
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 29 Mar 2012.
- Derived from this study: PubMed 21310305Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.
Related trials for Satiety
Not yet recruitingPhase 2
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Obesity & Overweight
Recruiting
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Prader-Willi Syndrome
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Recruiting
The Relationship Between Satiety Per Calorie (SPC) and Food Intake
Healthy
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.
Joanne L Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Fiber Supplement in people with Satiety, run by University of Minnesota 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 8 inclusion and 20 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 29 Mar 2012. 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. 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?
Satiety and Food Intake (time frame: November 2007 thru May 2008). 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 NCT00889993, 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 29 Mar 2012.