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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03297931
Other study ID # SPG_Snack Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 19, 2017
Est. completion date May 30, 2022

Study information

Verified date June 2021
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Consumers are often forced to eat fast, convenient foods and snacks ("eat on the go") in order to match the pace of their lifestyles. However, these snack options more often than not offer little health benefit to the consumer. In fact, 55% of calories consumed by Canadians are ultra processed foods, which are limited in their nutrient profile and only offer empty calories. Subsequently, these foods lead the consumer to eat more and provides little to no feelings of satiety or satiation. the proposed objectives of the current project are to examine the physiological benefit(s) of consuming readily available pulse snacks and compare them to other commonly consumed snack varieties. This work aims to incentivize consumers to seek out pulses as valuable snacking options and highlight the benefit of including these as alternatives to other energy-dense snacks that lack the nutritional composition of pulses.


Description:

Hypothesis of the study: Inclusion of pulses as part of a snack will lower appetite and post-prandial glycemia (PPG) in comparison to commercial, commonly consumed non-pulse snacks. Overall Objective of the study: To investigate and compare the effects of pulse and non-pulse snacks served as chips and dip on appetite and PPG in healthy adults. Specific objectives of the study: To test the acute effects of different pulse snacks on: 1) PPG and appetite for three hours, and 2) food intake 1 hour following consumption of snacks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 26
Est. completion date May 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Age: =18 and =45 years - BMI: = 18.5 and = 29.9 kg/m2 - Fasting serum glucose: = 5.6 mmol/L - Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. - Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the Department of Nutritional Sciences. Failure to comply will result in a rescheduled test visit. - Willing to abstain from alcohol consumption for 24 h prior to all test visits. - Willing to avoid vigorous physical activity for 24 h prior to all test visits. - Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: - Fasting blood glucose > 5.6 mmol/L - Smoking - Thyroid problems - Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease. - Presence of gastrointestinal disorder or surgeries within the past year. - Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement. - Patients who have undergone bariatric surgery at any point. - Known to be pregnant or lactating. - Unwillingness or inability to comply with the experimental procedures - Known intolerance, sensitivity or allergy to pulses or dairy. - Extreme dietary habits (ie. Atkins diet, very high protein diets, etc.). - Uncontrolled hypertension (systolic blood pressure = 140 mm Hg or diastolic blood pressure = 90 mm Hg) as defined by the average blood pressure measured at screening. - Weight gain or loss of at least 10 lbs in previous three months. - Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week) - Restrained Eaters

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Corn Chips + Onion Dip
Non-pulse chip + non-pulse dip
Yellow pea chip + hummus
Novel pulse chip + pulse spread
Pinto bean chip + hummus
Commercial pulse chip + pulse spread
Pinto bean chip + onion dip
Commercial pulse chip + non-pulse spread
Yellow pea chip + onion dip
Novel pulse chip + non-pulse spread
Corn chips + hummus
Non-pulse chip + pulse spread

Locations

Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood glucose levels Each participant will attend 6 sessions in total (randomized 6-arm cross-over design) Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 190 minutes (time of completion of each session)
Primary Subjective appetite Measured using Visual Analog Scales (VAS) Measured every 15-30 minutes up to 190 minutes
Primary Food intake Food intake is measured by the amount of pizza (in grams) consumed during the 20 minute period (pizza is served ad libitum) 65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption
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