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

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ClinicalTrials.gov Identifier: NCT03297931
Recruitment Status : Active, not recruiting
First Posted : September 29, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
G. Harvey Anderson, University of Toronto

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : July 19, 2017
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : September 30, 2018

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




Primary Outcome Measures :
  1. Change in blood glucose levels [ Time Frame: 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)

  2. Subjective appetite [ Time Frame: Measured every 15-30 minutes up to 190 minutes ]
    Measured using Visual Analog Scales (VAS)

  3. Food intake [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297931


Locations
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 3E2
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Harvey G Anderson, PhD University of Toronto

Responsible Party: G. Harvey Anderson, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03297931     History of Changes
Other Study ID Numbers: SPG_Snack Study
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by G. Harvey Anderson, University of Toronto:
Pulse
Snack
Post-prandial glycemia
Appetite
Food intake
Young adults
Satiety

Additional relevant MeSH terms:
Iproplatin
Antineoplastic Agents