ObesityNCT02465021
Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia
A study testing Dietary intervention in people with Obesity and Diabetes, run by University of Toronto at 1 site in Canada.
Trial summary
The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2
Who cannot join
- Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
- Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
- Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S3E2
About this study
The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.
- Being tested
- Dietary intervention
- Keywords
- Satiety, Food intake, Breakfast cereals/snacks, Postprandial glycemia
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
All arms are given to all participants, in a randomized order
| Study group | Role | What they receive |
|---|---|---|
| Snack bar 1 | Experimental | Dietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein Receives: Other: Dietary intervention |
| Snack bar 2 | Experimental | Dietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein Receives: Other: Dietary intervention |
| Snack bar 3 | Experimental | Dietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein Receives: Other: Dietary intervention |
| Control 1 | Experimental | Dietary intervention: Water (500 g) Receives: Other: Dietary intervention |
| Control 2 | Experimental | Dietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein) Receives: Other: Dietary intervention |
| Control 3 | Experimental | Dietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein) Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full
Measured: 120 minutes
Secondary outcomes (3)
Perceived satiety
Satiety scores (mm) are assessed using 100-mm "Motivation to Eat" visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the "Motivation to Eat" visual analog scale is calculated to obtain the average appetite score for statistical analysis
Measured: 120 minutes
Blood glucose
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Measured: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Blood insulin
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
Measured: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465021
- Sponsor's protocol ID
- 30422
- Status last verified
- Sep 2017
- First submitted
- 3 Jun 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia
- ClinicalTrials.gov ID
- NCT02465021
- Acronym / sponsor ID
- 30422
- Keywords
- Satiety, Food intake, Breakfast cereals/snacks, Postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jun 2015 (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 goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Snack bar 1 | Experimental | Other: Dietary interventionDietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein |
| Snack bar 2 | Experimental | Other: Dietary interventionDietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein |
| Snack bar 3 | Experimental | Other: Dietary interventionDietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein |
| Control 1 | Experimental | Other: Dietary interventionDietary intervention: Water (500 g) |
| Control 2 | Experimental | Other: Dietary interventionDietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein) |
| Control 3 | Experimental | Other: Dietary interventionDietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2
Key exclusion criteria (3 listed)
- Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
- Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
- Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet
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 |
|---|---|---|
| Dietary interventionAll arms are given to all participants, in a randomized order | Other | Control 1, Control 2, Control 3, Snack bar 1, Snack bar 2, Snack bar 3 |
Primary outcome
Food intake
Time frame: 120 minutes
Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full
3 secondary outcomes
Perceived satiety
Time frame: 120 minutes
Blood glucose
Time frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Blood insulin
Time frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
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 26 Sep 2017.
- Individual participant dataSharing planned: No
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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.
G. Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Obesity and Diabetes, run by University of Toronto at 1 site 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 1 inclusion and 3 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 26 Sep 2017. 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 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. 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?
Food intake (time frame: 120 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 26 Sep 2017.