NCT03297931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

6.5 years

First QC Date

September 25, 2017

Last Update Submit

March 24, 2025

Conditions

Keywords

PulseSnackPost-prandial glycemiaAppetiteFood intakeYoung adultsSatiety

Outcome Measures

Primary Outcomes (3)

  • 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)

  • Subjective appetite

    Measured using Visual Analog Scales (VAS)

    Measured every 15-30 minutes up to 190 minutes

  • 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

Study Arms (6)

Commercial corn chips + Onion dip

ACTIVE COMPARATOR

Corn chips + onion dip

Dietary Supplement: Corn Chips + Onion Dip

Commercial pulse chip + pulse spread

EXPERIMENTAL

Pinto bean chip + hummus

Dietary Supplement: Pinto bean chip + hummus

Novel pulse chip + pulse spread

EXPERIMENTAL

Yellow pea chip + hummus

Dietary Supplement: Yellow pea chip + hummus

Commercial pulse chip + non-pulse spread

EXPERIMENTAL

Pinto bean chip + onion dip

Dietary Supplement: Pinto bean chip + onion dip

Novel pulse chip + non-pulse spread

EXPERIMENTAL

Yellow pea chip + onion dip

Dietary Supplement: Yellow pea chip + onion dip

Non-pulse chip + pulse spread

EXPERIMENTAL

Corn chips + hummus

Dietary Supplement: Corn chips + hummus

Interventions

Corn Chips + Onion DipDIETARY_SUPPLEMENT

Non-pulse chip + non-pulse dip

Commercial corn chips + Onion dip
Yellow pea chip + hummusDIETARY_SUPPLEMENT

Novel pulse chip + pulse spread

Novel pulse chip + pulse spread
Pinto bean chip + hummusDIETARY_SUPPLEMENT

Commercial pulse chip + pulse spread

Commercial pulse chip + pulse spread
Pinto bean chip + onion dipDIETARY_SUPPLEMENT

Commercial pulse chip + non-pulse spread

Commercial pulse chip + non-pulse spread
Yellow pea chip + onion dipDIETARY_SUPPLEMENT

Novel pulse chip + non-pulse spread

Novel pulse chip + non-pulse spread
Corn chips + hummusDIETARY_SUPPLEMENT

Non-pulse chip + pulse spread

Non-pulse chip + pulse spread

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Harvey G Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 29, 2017

Study Start

July 19, 2017

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations