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

Sponsor

University of Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03297931

Collaborator

(none)

Enrollment

Location

Arms

58.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes	Dietary Supplement: Corn Chips + Onion Dip Dietary Supplement: Yellow pea chip + hummus Dietary Supplement: Pinto bean chip + hummus Dietary Supplement: Pinto bean chip + onion dip Dietary Supplement: Yellow pea chip + onion dip Dietary Supplement: Corn chips + hummus	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 19, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Commercial corn chips + Onion dip Corn chips + onion dip	Dietary Supplement: Corn Chips + Onion Dip Non-pulse chip + non-pulse dip
Experimental: Commercial pulse chip + pulse spread Pinto bean chip + hummus	Dietary Supplement: Pinto bean chip + hummus Commercial pulse chip + pulse spread
Experimental: Novel pulse chip + pulse spread Yellow pea chip + hummus	Dietary Supplement: Yellow pea chip + hummus Novel pulse chip + pulse spread
Experimental: Commercial pulse chip + non-pulse spread Pinto bean chip + onion dip	Dietary Supplement: Pinto bean chip + onion dip Commercial pulse chip + non-pulse spread
Experimental: Novel pulse chip + non-pulse spread Yellow pea chip + onion dip	Dietary Supplement: Yellow pea chip + onion dip Novel pulse chip + non-pulse spread
Experimental: Non-pulse chip + pulse spread Corn chips + hummus	Dietary Supplement: Corn chips + hummus Non-pulse chip + pulse spread

Outcome Measures

Primary Outcome Measures

Change in blood glucose levels [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)]
Each participant will attend 6 sessions in total (randomized 6-arm cross-over design)
Subjective appetite [Measured every 15-30 minutes up to 190 minutes]
Measured using Visual Analog Scales (VAS)
Food intake [65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption]
Food intake is measured by the amount of pizza (in grams) consumed during the 20 minute period (pizza is served ad libitum)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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