Food SelectionNCT02272153
Satiety Effects of the Combination of Egg and Whole Grains
A study testing Egg refined grain, Egg Whole Grain and Cereal Refined grain in people with Food Selection, run by University of Minnesota at 1 site in United States.
Trial summary
The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Egg refined grain, Egg Whole Grain and Cereal Refined grain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2014
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy,
- non-smoking,
- BMI of 18-27,
- non-dieting,
- typically consumes breakfast/lunch
Who cannot join
- distaste for eggs,
- vegetarian,
- current smoker,
- restrained eating habits,
- recent weight change,
- history of significant disease of past medical history,
- pregnant,
- lactating irregular menstrual cycle
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
Official title: The Effects of the Combination of Egg and Whole Grains on Appetite, Blood Glucose Response and Food Intake
The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.
Read the detailed description
Subjects will consume 3 different breakfast meals. Satiety will be measured by visual analogue scales; food intake will be recorded at subsequent meal as well as 24 hour food log; blood glucose response will be assessed following test meals. Subjects will consume an ad libitum lunch meal 3.5 hours after breakfast meal and food intake will be measured.
- Conditions
- Food Selection
- Being tested
- Egg refined grain, Egg Whole Grain, Cereal Refined grain
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg refined grainOther
Egg Whole GrainOther
Cereal Refined grainOther
| Study group | Role | What they receive |
|---|---|---|
| Egg refined grain | Active comparator | Eggs with white toast Receives: Other: Egg refined grain; Other: Egg Whole Grain; Other: Cereal Refined grain |
| Egg whole grain | Active comparator | Eggs with whole grain toast Receives: Other: Egg refined grain; Other: Egg Whole Grain; Other: Cereal Refined grain |
| Cereal Refined grain | Active comparator | rice cereal with white toast Receives: Other: Egg refined grain; Other: Egg Whole Grain; Other: Cereal Refined grain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
Measure satiety by visual analog scales (VAS)
Measured: 210 minutes
Secondary outcomes (2)
Food intake
ab libitum lunch provided to assess food intake variation between treatments
Measured: 210 minutes
Blood glucose response
blood glucose response via finger stick following test meals
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272153
- Sponsor's protocol ID
- 1310M44503
- Status last verified
- Jan 2015
- First submitted
- 20 Oct 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Combination of Egg and Whole Grains on Appetite, Blood Glucose Response and Food Intake
- ClinicalTrials.gov ID
- NCT02272153
- Acronym / sponsor ID
- 1310M44503
- Conditions
- Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Oct 2014 (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.
The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.
Detailed description
Subjects will consume 3 different breakfast meals. Satiety will be measured by visual analogue scales; food intake will be recorded at subsequent meal as well as 24 hour food log; blood glucose response will be assessed following test meals. Subjects will consume an ad libitum lunch meal 3.5 hours after breakfast meal and food intake will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Egg refined grain | Active comparator | Other: Egg refined grain, Other: Egg Whole Grain, Other: Cereal Refined grainEggs with white toast |
| Egg whole grain | Active comparator | Other: Egg refined grain, Other: Egg Whole Grain, Other: Cereal Refined grainEggs with whole grain toast |
| Cereal Refined grain | Active comparator | Other: Egg refined grain, Other: Egg Whole Grain, Other: Cereal Refined grainrice cereal with white toast |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy,
- non-smoking,
- BMI of 18-27,
- non-dieting,
- typically consumes breakfast/lunch
Key exclusion criteria (8 listed)
- distaste for eggs,
- vegetarian,
- current smoker,
- restrained eating habits,
- recent weight change,
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 |
|---|---|---|
| Egg refined grain | Other | Cereal Refined grain, Egg refined grain, Egg whole grain |
| Egg Whole Grain | Other | Cereal Refined grain, Egg refined grain, Egg whole grain |
| Cereal Refined grain | Other | Cereal Refined grain, Egg refined grain, Egg whole grain |
Primary outcome
Satiety
Time frame: 210 minutes
Measure satiety by visual analog scales (VAS)
2 secondary outcomes
Food intake
Time frame: 210 minutes
Blood glucose response
Time frame: 180 minutes
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 15 Jan 2015.
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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 Egg refined grain, Egg Whole Grain and Cereal Refined grain in people with Food Selection, 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 5 inclusion and 8 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 15 Jan 2015. 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 (time frame: 210 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2015.