Comparison of Pulse Chips and Commercial Snacks on Food Intake, Appetite and Blood Glucose in Healthy Young Adults

Obesity Clinical Trial

Official title:

Comparison of Roasted Pulse Snacks, Pulse Chips and Commercial Snacks on Post-prandial Food Intake, Appetite and Glycemic Response in Healthy Young Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03297931
• Other study ID #: SPG_Snack Study
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Obesity

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