AppetiteNCT02111486
Effect of Certain Breakfasts on Appetite Control
A study testing breakfast in people with Appetite and Post-prandial Glucose Response, run by St. Boniface Hospital at 2 sites in Canada.
Trial summary
This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite, Post-prandial Glucose Response
- What is being tested?
- breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2015to Oct 2015
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.
- Body mass index: 18.5-30 kg/m2.
Who cannot join
- A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- Daily tobacco use.
- Physical Activity Level >1.8.
- Eat meals at irregular or unusual times.
- Food allergy, aversion or unwillingness to eat study foods.
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar.
Show all 9Show fewer
- Presence of a gastrointestinal disorder.
- Taking drugs that affect gastric emptying.
- Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.
This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.
Read the detailed description
The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).
- Conditions
- Appetite, Post-prandial Glucose Response
- Being tested
- breakfast
- Keywords
- Breakfast, Satiety, Fibre, Glucose, Gastric emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| breakfast #1 | Experimental | breakfast food containing high viscosity fibre Receives: Other: breakfast |
| breakfast #2 | Experimental | breakfast food containing low viscosity fibre Receives: Other: breakfast |
| Control | Placebo comparator | breakfast food without viscous fibre Receives: Other: breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales
Measured: before the breakfast and every 30 minutes after breakfast for 4 hours
Gastric emptying rate
13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples.
Measured: before the breakfast and every 15 minutes after breakfast for 4 hours
Secondary outcomes (2)
Glucose and Insulin
Total area under the curve (iAUC, mmol*min/L) for both glucose and insulin
Measured: before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.
Kilocalories
Measure the amount of kilocalories consumed throughout each test day.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather Blewett, Ph.D, Principal investigator, I.H. Asper Clinical Research Institute/Agriculture and Agri-Food CanadaNancy Ames, PhD, Principal investigator, Richardson Centre for Functional Foods and Nutraceuticals/Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111486
- Sponsor's protocol ID
- B2014:027
- Status last verified
- Oct 2016
- First submitted
- 9 Apr 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck EJ, Tosh SM, Batterham MJ, Tapsell LC, Huang XF. Oat beta-glucan increases postprandial cholecystokinin levels, decreases insulin response and extends subjective satiety in overweight subjects. Mol Nutr Food Res. 2009 Oct;53(10):1343-51. doi: 10.1002/mnfr.200800343.
PubMed 19753601Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
PubMed 20122136Pentikainen S, Karhunen L, Flander L, Katina K, Meynier A, Aymard P, Vinoy S, Poutanen K. Enrichment of biscuits and juice with oat beta-glucan enhances postprandial satiety. Appetite. 2014 Apr;75:150-6. doi: 10.1016/j.appet.2014.01.002. Epub 2014 Jan 14.
PubMed 24434584Thondre PS, Henry CJ. High-molecular-weight barley beta-glucan in chapatis (unleavened Indian flatbread) lowers glycemic index. Nutr Res. 2009 Jul;29(7):480-6. doi: 10.1016/j.nutres.2009.07.003.
PubMed 19700035de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.
PubMed 15159223
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.
- ClinicalTrials.gov ID
- NCT02111486
- Acronym / sponsor ID
- B2014:027
- Conditions
- Appetite, Post-prandial Glucose Response
- Keywords
- Breakfast, Satiety, Fibre, Glucose, Gastric emptying
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Apr 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.
This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.
Detailed description
The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breakfast #1 | Experimental | Other: breakfastbreakfast food containing high viscosity fibre |
| breakfast #2 | Experimental | Other: breakfastbreakfast food containing low viscosity fibre |
| Control | Placebo comparator | Other: breakfastbreakfast food without viscous fibre |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.
- Body mass index: 18.5-30 kg/m2.
Key exclusion criteria (9 listed)
- A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- Daily tobacco use.
- Physical Activity Level >1.8.
- Eat meals at irregular or unusual times.
- Food allergy, aversion or unwillingness to eat study foods.
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 |
|---|---|---|
| breakfast | Other | Control, breakfast #1, breakfast #2 |
Primary outcome
Satiety
Time frame: before the breakfast and every 30 minutes after breakfast for 4 hours
Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales
Gastric emptying rate
Time frame: before the breakfast and every 15 minutes after breakfast for 4 hours
13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples.
2 secondary outcomes
Glucose and Insulin
Time frame: before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.
Kilocalories
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 19753601Beck EJ, Tosh SM, Batterham MJ, Tapsell LC, Huang XF. Oat beta-glucan increases postprandial cholecystokinin levels, decreases insulin response and extends subjective satiety in overweight subjects. Mol Nutr Food Res. 2009 Oct;53(10):1343-51. doi: 10.1002/mnfr.200800343.
- Background: PubMed 20122136Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
- Background: PubMed 24434584Pentikainen S, Karhunen L, Flander L, Katina K, Meynier A, Aymard P, Vinoy S, Poutanen K. Enrichment of biscuits and juice with oat beta-glucan enhances postprandial satiety. Appetite. 2014 Apr;75:150-6. doi: 10.1016/j.appet.2014.01.002. Epub 2014 Jan 14.
- Background: PubMed 19700035Thondre PS, Henry CJ. High-molecular-weight barley beta-glucan in chapatis (unleavened Indian flatbread) lowers glycemic index. Nutr Res. 2009 Jul;29(7):480-6. doi: 10.1016/j.nutres.2009.07.003.
- Background: PubMed 15159223de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.
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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.
Heather Blewett, Ph.D principal investigator
I.H. Asper Clinical Research Institute/Agriculture and Agri-Food Canada
Nancy Ames, PhD principal investigator
Richardson Centre for Functional Foods and Nutraceuticals/Agriculture and Agri-Food Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breakfast in people with Appetite and Post-prandial Glucose Response, run by St. Boniface Hospital at 2 sites in Canada.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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: before the breakfast and every 30 minutes after breakfast for 4 hours). The study lists 2 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 NCT02111486, which also lists 5 linked publications.
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 18 Oct 2016.