Food Intake RegulationNCT01712737
The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children
A study testing Dietary intervention in people with Food Intake Regulation, run by University of Toronto.
Trial summary
No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Intake Regulation
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: healthy boys and girls between 8-11 y Exclusion criteria: learning and behavioral problems
About this study
No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on appetite and food intake 30 min later in 8 - 11 y old normal weight children. The investigators hypothesized that raisins would lower subsequent energy intake in children and reduce hunger.
- Conditions
- Food Intake Regulation
- Being tested
- Dietary intervention
- Keywords
- raisins, grapes, snacks, appetite, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Snack foods: raisins | Experimental | children were given ad libitum access to raisins for 15 min Receives: Other: Dietary intervention |
| Snack foods: grapes | Experimental | children were given ad libitum access to grapes for 15 min Receives: Other: Dietary intervention |
| Snack foods: a mix of almonds with raisins | Experimental | children were given ad libitum access to a mix of almonds with raisins for 15 min Receives: Other: Dietary intervention |
| Water control | Experimental | children were given ad libitum access to water Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad libitum snack intake (kcal)
Measured: 15 min
ad libitum pizza intake (kcal)
Measured: at 30 min after treatment
Secondary outcomes (1)
subjective appetite
Measured: 0-105 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Intake RegulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Saint Vincent University, Toronto Metropolitan University, California Raisin Marketing Board
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712737
- Sponsor's protocol ID
- Raisins_part1_UofT
- Status last verified
- Oct 2012
- First submitted
- 20 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children
- ClinicalTrials.gov ID
- NCT01712737
- Acronym / sponsor ID
- Raisins_part1_UofT
- Conditions
- Food Intake Regulation
- Keywords
- raisins, grapes, snacks, appetite, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mount Saint Vincent University, Toronto Metropolitan University, California Raisin Marketing Board
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Oct 2012 (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.
No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on appetite and food intake 30 min later in 8 - 11 y old normal weight children. The investigators hypothesized that raisins would lower subsequent energy intake in children and reduce hunger.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Snack foods: raisins | Experimental | Other: Dietary interventionchildren were given ad libitum access to raisins for 15 min |
| Snack foods: grapes | Experimental | Other: Dietary interventionchildren were given ad libitum access to grapes for 15 min |
| Snack foods: a mix of almonds with raisins | Experimental | Other: Dietary interventionchildren were given ad libitum access to a mix of almonds with raisins for 15 min |
| Water control | Experimental | Other: Dietary interventionchildren were given ad libitum access to water |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 intervention | Other | Snack foods: a mix of almonds with raisins, Snack foods: grapes, Snack foods: raisins, Water control |
Primary outcome
ad libitum snack intake (kcal)
Time frame: 15 min
ad libitum pizza intake (kcal)
Time frame: at 30 min after treatment
1 secondary outcome
subjective appetite
Time frame: 0-105 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 29 Oct 2012.
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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.
Harvey Anderson, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Food Intake Regulation, run by University of Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
ad libitum snack intake (kcal) (time frame: 15 min). 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?
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 Oct 2012.