Healthy CanadiansNCT01806688

Effect of Snacks on Appetite Control

A study testing gluten-free high protein snack #1, gluten-free snack with similar energy density but 1/2 the protein as snack #1 and gluten-free high protein and high fibre snack #2 in people with Healthy Canadians and Appetite Control, run by St. Boniface Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial is being conducted to study whether eating certain snacks will reduce your desire to eat and for a longer period of time compared to other snacks. The investigators are testing 2 different snacks. Study #1 will involve eating 2 different seed-like snacks or water. Read more about this study

Who is it for?: Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Canadians, Appetite Control
What is being tested?: gluten-free high protein snack #1, gluten-free snack with similar energy density but 1/2 the protein as snack #1 and gluten-free high protein and high fibre snack #2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteCanada
Study dates: 6 Jul 2013to 23 Aug 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index 18-30kg/m2
males and non-pregnant or non-lactating females

Who cannot join

Diagnosis of disease by a medical doctor that requires medical treatment during the study period.
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.
Presence of a gastrointestinal disorder.
Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.

Trial locations and contacts

1 site in 1 country.

Canada1 site

I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control

Read the detailed description

Healthy adults will be recruited to participate in a randomized, controlled, crossover study to investigate whether or not eating snacks made with buckwheat would increase satiety and reduce their energy intake when compared to a comparable snack. Water was included as a non-caloric control. The study consisted of 3 visits and participants would receive a different treatment at each visit. Visits were scheduled at least 7 days apart. Visual analog scales will be used to assess appetite related sensations at 7 time points, fasting, 30 minutes after consuming the snack and then at 30 minute intervals for 180 minutes. Participants will be provided with a lunch and the amount of food consumed will be weighed. I addition, participants will be asked to maintain a food record for the remainder of the day.

Conditions: Healthy Canadians, Appetite Control
Being tested: gluten-free high protein snack #1, gluten-free snack with similar energy density but 1/2 the protein as snack #1, non-caloric control, gluten-free high protein and high fibre snack #2, gluten-free snack with similar energy density, but less protein and fibre than snack #2
Keywords: satiety, appetite, snack

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gluten-free high protein snack #1Other
buckwheat groats 30g serving
gluten-free snack with similar energy density but 1/2 the protein as snack #1Other
32g serving of corn nuts
non-caloric controlOther
water
gluten-free high protein and high fibre snack #2Other
buckwheat and pinto bean flour pita bread 50g serving
gluten-free snack with similar energy density, but less protein and fibre than snack #2Other
50g serving of rice bread

Study groups in NCT01806688
Study group	Role	What they receive
Experimental Snack #1	Experimental	One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water. Receives: Other: gluten-free high protein snack #1; Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1; Other: non-caloric control
Experimental Snack #2	Experimental	One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of a buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water. Receives: Other: non-caloric control; Other: gluten-free high protein and high fibre snack #2; Other: gluten-free snack with similar energy density, but less protein and fibre than snack #2

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)
Appetite assessment was measured using a VAS questionnaire administered pre-snack and every 30 minutes post snack up to 180 minutes, for a total of 7 time points. The questionnaire included 4 questions (1) How hungry are you? (2) How full are you? (3) How strong is your desire to eat? (4) How much do you think you want to eat right now? Each question was followed by a 10 cm line anchored at the left and right ends by the opposing statements "not at all" and "extremely" for questions 1 and 2, "very weak " and "very strong" for question 3, and "nothing at all" and "a very large amount" for question 4. Participants provided their response to each question by marking a perpendicular line on the 10-cm line to indicate their answer. Scores were determined by measuring the distance in centimeters from the left anchor to the perpendicular line drawn by the participant. VAS scores over time were graphed and AUC was calculated using the trapezoid method.
Measured: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.

Secondary outcomes (1)

Number of Calories Consumed Post-snack Until Bedtime
Participants were provided with a food diary to record the amount and type of each food and beverage consumed for the remainder of the day. Energy consumed at lunch and the remainder of the day were quantified from food consumed at lunch and the food diary using Food Processor Nutrient Analysis Software.
Measured: time between snack consumption and bedtime (12 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 201323 Aug 2014

First posted7 Mar 2013 (estimated)
Study start6 Jul 2013
Primary completion23 Aug 2014
Study completion23 Aug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Healthy CanadiansStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01806688
Sponsor's protocol ID: H2013:036
Other IDs: RRC/2013/1276
Status last verified: Aug 2021
First submitted: 5 Mar 2013
Last updated: 12 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Group results will be emailed or mailed to individuals upon request once they are available.

Publications

Blundell 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 20122136
Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.
PubMed 18469287
Belski R. Fiber, protein, and lupin-enriched foods: role for improving cardiovascular health. Adv Food Nutr Res. 2012;66:147-215. doi: 10.1016/B978-0-12-394597-6.00004-5.
PubMed 22909980

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2021. 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 Snacks on Appetite Control
ClinicalTrials.gov ID: NCT01806688
Acronym / sponsor ID: H2013:036
Conditions: Healthy Canadians, Appetite Control
Keywords: satiety, appetite, snack
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: St. Boniface HospitalUniversity, hospital or other
Collaborators: Manitoba Agri-Health Research Network
Study start: 6 Jul 2013 (actual)
Primary completion: 23 Aug 2014 (actual)
Study completion: 23 Aug 2014 (actual)
First posted: 7 Mar 2013 (estimated)
Results: Posted 12 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized crossover

Arm	Type	Receives
Experimental Snack #1	Experimental	Other: gluten-free high protein snack #1, Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1, Other: non-caloric controlOne of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
Experimental Snack #2	Experimental	Other: non-caloric control, Other: gluten-free high protein and high fibre snack #2, Other: gluten-free snack with similar energy density, but less protein and fibre than snack #2One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of a buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Body mass index 18-30kg/m2
males and non-pregnant or non-lactating females

Key exclusion criteria (8 listed)

Diagnosis of disease by a medical doctor that requires medical treatment during the study period.
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
gluten-free high protein snack #1buckwheat groats 30g serving	Other	Experimental Snack #1
gluten-free snack with similar energy density but 1/2 the protein as snack #132g serving of corn nuts	Other	Experimental Snack #1
non-caloric controlwater	Other	Experimental Snack #1, Experimental Snack #2
gluten-free high protein and high fibre snack #2buckwheat and pinto bean flour pita bread 50g serving	Other	Experimental Snack #2
gluten-free snack with similar energy density, but less protein and fibre than snack #250g serving of rice bread	Other	Experimental Snack #2

Primary outcome

Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)
Time frame: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.
Appetite assessment was measured using a VAS questionnaire administered pre-snack and every 30 minutes post snack up to 180 minutes, for a total of 7 time points. The questionnaire included 4 questions (1) How hungry are you? (2) How full are you? (3) How strong is your desire to eat? (4) How much do you think you want to eat right now? Each question was followed by a 10 cm line anchored at the left and right ends by the opposing statements "not at all" and "extremely" for questions 1 and 2, "very weak " and "very strong" for question 3, and "nothing at all" and "a very large amount" for question 4. Participants provided their response to each question by marking a perpendicular line on the 10-cm line to indicate their answer. Scores were determined by measuring the distance in centimeters from the left anchor to the perpendicular line drawn by the participant. VAS scores over time were graphed and AUC was calculated using the trapezoid method.

1 secondary outcome

Number of Calories Consumed Post-snack Until Bedtime
Time frame: time between snack consumption and bedtime (12 hours)

Results and safety

Results posted to the registry on 12 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seed Study	38	38
Pita Study	0	0

Primary outcome: Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)

Time frame: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.. Least squares mean (Standard Error). Unit: cm x min

Measure	Seed Study n = 37	Pita Study n = 37
Seed Study Experimental Snack #1 Hunger	651 (46)	–
Seed Study Experimental Snack #1 Fullness	1008 (46)	–
Seed Study Experimental Snack #1 Desire	638 (46)	–
Seed Study Experimental Snack #1 Consume	640 (42)	–
Seed Study Placebo Comparator #1 Hunger	636 (46)	–
Seed Study Placebo Comparator #1 Fullness	1024 (46)	–
Seed Study Placebo Comparator #1 Desire	659 (46)	–
Seed Study Placebo Comparator #1 Consume	649 (42)	–

Seed Study vs Pita Study: p <0.05, ANCOVA

Population analysed: A total of 46 participants were enrolled in the Seed and the Pita Study. Of these 46, 30 participated in both studies and 16 enrolled in just one study. 38 participants enrolled in the Seed Study and 38 in the Pita Study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: No adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Seed Study	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Pita Study	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 18469287Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.
Background: PubMed 22909980Belski R. Fiber, protein, and lupin-enriched foods: role for improving cardiovascular health. Adv Food Nutr Res. 2012;66:147-215. doi: 10.1016/B978-0-12-394597-6.00004-5.
Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian Institute for Health InformationLink provided by the sponsor.
Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrationsLink provided by the sponsor.
Draft guidance document: Satiety health claims on food from Health CanadaLink provided by the sponsor.
Individual participant dataSharing planned: No. Group results will be emailed or mailed to individuals upon request once they are available.

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 J Blewett, PhD principal investigator

St. Boniface Hospital Research Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 12 Aug 2021. 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?

Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) (time frame: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.). 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 NCT01806688, which also lists 3 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 12 Aug 2021.