Appetite Control, Healthy Canadians
Conditions
Keywords
satiety, appetite, snack
Brief 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. Study #2 will involve eating pita bread with jam, bread with jam or water. The test snack is higher in protein and/or fibre compared to the reference product.
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.
Interventions
OTHERgluten-free high protein snack #1
buckwheat groats 30g serving
OTHERgluten-free snack with similar energy density but 1/2 the protein as snack #1
32g serving of corn nuts
OTHERnon-caloric control
water
OTHERgluten-free high protein and high fibre snack #2
buckwheat and pinto bean flour pita bread 50g serving
OTHERgluten-free snack with similar energy density, but less protein and fibre than snack #2
50g serving of rice bread
Sponsors
Manitoba Agri-Health Research Network
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Randomized crossover
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18-30kg/m2 * males and non-pregnant or non-lactating females
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Calories Consumed Post-snack Until Bedtime | time between snack consumption and bedtime (12 hours) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Side Effects | 24h | Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded. |
| Likeability of Test and Reference Products Based on Sensory Scales | immediately after eating test or reference product | Likability of the study products was assessed using a 5-point hedonic scale (1 = dislike extremely; 2 = dislike very moderately; 3 = neither like or dislike; 4 = like moderately; 5 = like extremely) for appearance, aroma, flavour, taste, texture and overall liking. |
Countries
Canada
Participant flow
Recruitment details
289 candidates were screened between June 2013 and August 2014. Of these 289 candidates, 50 met the criteria and were determined to be eligible. The first participant was enrolled on July 6, 2013 and the last participant enrolled August 9, 2014. 46 participants were enrolled in the overall study and 30 of these completed both the seed study and the pita study while 16 participated in only one of the studies. 38 participants were randomized to the seed study and 38 to the pita study.
Pre-assignment details
30 people completed both studies and 16 participated in only 1 study.
Participants by arm
| Arm | Count |
|---|---|
| Seed Study 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. | 38 |
| Pita Study 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 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. | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Seed Study | Pita Study | Total |
|---|---|---|---|
| Age, Categorical Pita Study <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Pita Study >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Pita Study Between 18 and 65 years | 0 Participants | 37 Participants | 37 Participants |
| Age, Categorical Seed Study <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Seed Study >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Seed Study Between 18 and 65 years | 37 Participants | 0 Participants | 37 Participants |
| Age, Continuous Pita Study | — | 33.5 years | 33.5 years |
| Age, Continuous Seed Study | 37.7 years | — | 37.7 years |
| Race (NIH/OMB) Pita Study American Indian or Alaska Native | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Pita Study Asian | — | 11 Participants | 11 Participants |
| Race (NIH/OMB) Pita Study Black or African American | — | 1 Participants | 1 Participants |
| Race (NIH/OMB) Pita Study More than one race | — | 3 Participants | 3 Participants |
| Race (NIH/OMB) Pita Study Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Pita Study Unknown or Not Reported | — | 3 Participants | 3 Participants |
| Race (NIH/OMB) Pita Study White | — | 20 Participants | 20 Participants |
| Race (NIH/OMB) Seed Study American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Seed Study Asian | 9 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Seed Study Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Seed Study More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Seed Study Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Seed Study Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Seed Study White | 24 Participants | 0 Participants | 24 Participants |
| Region of Enrollment Canada | 38 Participants | 0 Participants | 38 Participants |
| Sex: Female, Male Pita Study Female | 0 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Pita Study Male | 0 Participants | 27 Participants | 27 Participants |
| Sex: Female, Male Seed Study Female | 10 Participants | 0 Participants | 10 Participants |
| Sex: Female, Male Seed Study Male | 28 Participants | 0 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
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.
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.
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Experimental Snack #1 Fullness | 1008 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Experimental Snack #1 Hunger | 651 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Experimental Snack #1 Desire | 638 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Experimental Snack #1 Consume | 640 cm x min | Standard Error 42 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator #1 Hunger | 636 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator #1 Fullness | 1024 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator #1 Desire | 659 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator #1 Consume | 649 cm x min | Standard Error 42 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator #1 Non-caloric Control Hunger | 962 cm x min | Standard Error 46 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Control #1 Non-caloric Control Fullness | 682 cm x min | Standard Error 47 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Control #1 Non-caloric Control Desire | 980 cm x min | Standard Error 47 |
| Seed Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Seed Study Placebo Comparator Non-caloric Control #1 Consume | 916 cm x min | Standard Error 42 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Experimental Snack #2 Hunger | 611 cm x min | Standard Error 40 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Experimental Snack #2 Fullness | 1005 cm x min | Standard Error 41 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Experimental Snack #2 Desire | 616 cm x min | Standard Error 44 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Experimental Snack #2 Consume | 599 cm x min | Standard Error 38 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Reference Product Hunger | 661 cm x min | Standard Error 39 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Reference Product Fullness | 968 cm x min | Standard Error 40 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Reference Product Desire | 682 cm x min | Standard Error 43 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Reference Product Consume | 676 cm x min | Standard Error 38 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Non-caloric Control Hunger | 956 cm x min | Standard Error 39 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Non-caloric Control Fullness | 675 cm x min | Standard Error 40 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Non-caloric Control Desire | 1001 cm x min | Standard Error 43 |
| Pita Study | Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) | Pita Study Placebo Comparator #2 Non-caloric Control Consume | 959 cm x min | Standard Error 38 |
Comparison: Items #1 were compared to each other and Items #2 were compared to each otherp-value: <0.05ANCOVA
Secondary
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.
Time frame: time between snack consumption and bedtime (12 hours)
Population: In the Seed Study data for 36 participants was analyzed. One participant was not analyzed due to non compliance and a second participant for not providing a food record. In the Pita Study data from 34 participants was analyzed. One participant was noncompliant and 3 did not turn in food records.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seed Study | Number of Calories Consumed Post-snack Until Bedtime | Seed Study Experimental Snack #1 | 1429 kcal | Standard Error 70 |
| Seed Study | Number of Calories Consumed Post-snack Until Bedtime | Seed Study Placebo Comparator #1 Reference Product | 1326 kcal | Standard Error 94 |
| Seed Study | Number of Calories Consumed Post-snack Until Bedtime | Seed Study Placebo Comparator #1 Non-caloric Control | 1288 kcal | Standard Error 80 |
| Pita Study | Number of Calories Consumed Post-snack Until Bedtime | Pita Study Experimental Snack #2 | 1448 kcal | Standard Error 89 |
| Pita Study | Number of Calories Consumed Post-snack Until Bedtime | Pita Study Placebo Comparator #2 Reference Product | 1414 kcal | Standard Error 78 |
| Pita Study | Number of Calories Consumed Post-snack Until Bedtime | Pita Study Placebo Comparator #2 Non-caloric Control | 1478 kcal | Standard Error 75 |
Comparison: Items #1 were compared to each other and Items #2 were compared to each otherp-value: <0.05ANCOVA
Other Pre-specified
Gastrointestinal Side Effects
Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded.
Time frame: 24h
Other Pre-specified
Likeability of Test and Reference Products Based on Sensory Scales
Likability of the study products was assessed using a 5-point hedonic scale (1 = dislike extremely; 2 = dislike very moderately; 3 = neither like or dislike; 4 = like moderately; 5 = like extremely) for appearance, aroma, flavour, taste, texture and overall liking.
Time frame: immediately after eating test or reference product
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack taste | 3.57 sensory rating on a scale of 1 to 5 | Standard Error 0.2 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack texture | 3.66 sensory rating on a scale of 1 to 5 | Standard Error 0.19 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack appearance | 3.57 sensory rating on a scale of 1 to 5 | Standard Error 0.16 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack overall | 3.48 sensory rating on a scale of 1 to 5 | Standard Error 0.18 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack aroma | 3.4 sensory rating on a scale of 1 to 5 | Standard Error 0.11 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference taste | 3.23 sensory rating on a scale of 1 to 5 | Standard Error 0.2 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference texture | 2.64 sensory rating on a scale of 1 to 5 | Standard Error 0.19 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference appearance | 3.49 sensory rating on a scale of 1 to 5 | Standard Error 0.16 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference aroma | 3.34 sensory rating on a scale of 1 to 5 | Standard Error 0.11 |
| Seed Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference overall | 3.05 sensory rating on a scale of 1 to 5 | Standard Error 0.18 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference appearance | 3.74 sensory rating on a scale of 1 to 5 | Standard Error 0.14 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack taste | 3.66 sensory rating on a scale of 1 to 5 | Standard Error 0.15 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference taste | 3.67 sensory rating on a scale of 1 to 5 | Standard Error 0.15 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack texture | 3.49 sensory rating on a scale of 1 to 5 | Standard Error 0.19 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference overall | 3.58 sensory rating on a scale of 1 to 5 | Standard Error 0.14 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack appearance | 3.81 sensory rating on a scale of 1 to 5 | Standard Error 0.14 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference texture | 3.36 sensory rating on a scale of 1 to 5 | Standard Error 0.19 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack overall | 3.64 sensory rating on a scale of 1 to 5 | Standard Error 0.15 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Placebo Comparator Reference aroma | 3.39 sensory rating on a scale of 1 to 5 | Standard Error 0.1 |
| Pita Study | Likeability of Test and Reference Products Based on Sensory Scales | Experimental Snack aroma | 3.45 sensory rating on a scale of 1 to 5 | Standard Error 0.1 |
Comparison: Items #1 were compared to each other and Items #2 were compared to each otherp-value: <0.05ANCOVA