SatietyNCT03207607
Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake
A study testing Maltodextrin snack, Whey protein snack and Oat snack in people with Satiety and Food Intake, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety, Food Intake
- What is being tested?
- Maltodextrin snack, Whey protein snack and Oat snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Aug 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between 18 and 30 years of age
- be healthy, non-smoking and not be taking any medications, including birth control
- body mass index (BMI) between 20 and 24.9
Who cannot join
- fasting plasma glucose >5.5 mmol/L
- health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
- major medical or surgical event within the past 6 months
- current or recent dieting
- breakfast skipping
- receiving any medications
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- menstrual irregularities
- food sensitivities, allergies, intolerances, or dietary restrictions to foods including: cereal, orange juice, dairy, oat, coconut oil, honey, apple, pineapple, strawberry, and pear
- behavioural or emotional problems
- alcohol consumption >7 beverages/week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mid-Morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake in Healthy Adults
The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.
Read the detailed description
23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a control snack and four modified snacks containing whey protein, oats, coconut oil or maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12 hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60, 90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at the same time VAS measurements were taken. Food intake was measured via ad libitum pizza lunch.
- Conditions
- Satiety, Food Intake
- Being tested
- Control snack, Maltodextrin snack, Whey protein snack, Oat snack, Coconut oil snack
- Keywords
- Adults, Snacks, Appetite, Blood glucose, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control snackOther
Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal)
Maltodextrin snackOther
Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal)
Whey protein snackOther
Isovolumetric (238.4g) gel snack with whey protein (201.8kcal)
Oat snackOther
Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal)
Coconut oil snackOther
Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal)
Snack skippingOther
no snack
| Study group | Role | What they receive |
|---|---|---|
| Control snack | Experimental | Participants received control snacks prepared by real fruits (pear, orange and mango) Receives: Other: Control snack |
| Maltodextrin snack | Experimental | Participants received maltodextrin snacks (maltodextrin + control snack) Receives: Other: Maltodextrin snack |
| Whey protein snack | Experimental | Participants received whey protein snacks (whey protein + control snack) Receives: Other: Whey protein snack |
| Oat snack | Experimental | Participants received oat snacks (oat + maltodextrin + control snack) Receives: Other: Oat snack |
| Coconut oil snack | Experimental | Participants received coconut oil snacks (coconut oil + control snack) Receives: Other: Coconut oil snack |
| Snack skipping | Experimental | Participants received snack skipping Receives: Other: Snack skipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Appetite
Participants completed subjective ratings on appetite (e.g., desire to eat, hunger, fullness, prospective food consumption) and well-being at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch.
Measured: Change from baseline over 120 minutes
Secondary outcomes (3)
Blood Glucose Response
Blood was collected at baseline (0min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch to observe glycemic responses to gel snacks
Measured: Change from baseline over 120 minutes
Blood Insulin Response
Blood was collected at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after meal consumption, as well as immediately following lunch, to observe insulin responses to gel snacks
Measured: Change from baseline over 120 minutes
Food Intake
Participants consumed an ad libitum pizza lunch at 120 minutes
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hershey Company
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan UniversityDerick Rousseau, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207607
- Sponsor's protocol ID
- REB2015-405
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mid-Morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT03207607
- Acronym / sponsor ID
- REB2015-405
- Conditions
- Satiety, Food Intake
- Keywords
- Adults, Snacks, Appetite, Blood glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- The Hershey Company
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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 purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.
Detailed description
23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a control snack and four modified snacks containing whey protein, oats, coconut oil or maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12 hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60, 90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at the same time VAS measurements were taken. Food intake was measured via ad libitum pizza lunch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control snack | Experimental | Other: Control snackParticipants received control snacks prepared by real fruits (pear, orange and mango) |
| Maltodextrin snack | Experimental | Other: Maltodextrin snackParticipants received maltodextrin snacks (maltodextrin + control snack) |
| Whey protein snack | Experimental | Other: Whey protein snackParticipants received whey protein snacks (whey protein + control snack) |
| Oat snack | Experimental | Other: Oat snackParticipants received oat snacks (oat + maltodextrin + control snack) |
| Coconut oil snack | Experimental | Other: Coconut oil snackParticipants received coconut oil snacks (coconut oil + control snack) |
| Snack skipping | Experimental | Other: Snack skippingParticipants received snack skipping |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- be between 18 and 30 years of age
- be healthy, non-smoking and not be taking any medications, including birth control
- body mass index (BMI) between 20 and 24.9
Key exclusion criteria (10 listed)
- fasting plasma glucose >5.5 mmol/L
- health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
- major medical or surgical event within the past 6 months
- current or recent dieting
- breakfast skipping
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 |
|---|---|---|
| Control snackIsovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal) | Other | Control snack |
| Maltodextrin snackIsovolumetric (238.4g) gel snack with maltodextrin (271.8kcal) | Other | Maltodextrin snack |
| Whey protein snackIsovolumetric (238.4g) gel snack with whey protein (201.8kcal) | Other | Whey protein snack |
| Oat snackIsovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal) | Other | Oat snack |
| Coconut oil snackIsovolumetric (238.4g) gel snack with coconut oil (276.4kcal) | Other | Coconut oil snack |
| Snack skippingno snack | Other | Snack skipping |
Primary outcome
Subjective Appetite
Time frame: Change from baseline over 120 minutes
Participants completed subjective ratings on appetite (e.g., desire to eat, hunger, fullness, prospective food consumption) and well-being at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch.
3 secondary outcomes
Blood Glucose Response
Time frame: Change from baseline over 120 minutes
Blood Insulin Response
Time frame: Change from baseline over 120 minutes
Food Intake
Time frame: 30 min
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 5 Jul 2017.
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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
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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.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
Derick Rousseau, PhD principal investigator
Toronto Metropolitan 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 Maltodextrin snack, Whey protein snack and Oat snack in people with Satiety and Food Intake, run by Toronto Metropolitan University 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 3 inclusion and 10 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 5 Jul 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?
Subjective Appetite (time frame: Change from baseline over 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 5 Jul 2017.