- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223935
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
January 19, 2023 updated by: University of Manitoba
A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted.
The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds.
They will be matched for calorie content and provided in 200 kcal servings.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 6C5
- Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI: ≥18.5 and ≤29.9 kg/m2
- Fasting serum glucose: ≤5.5 mmol/L
Exclusion Criteria:
- Fasting serum glucose > 5.5 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 a 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 judgment
- Known to be pregnant or lactating
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- Weight gain or loss of at least 10lbs in previous three months
- Excessive alcohol intake
- Restrained Eaters (identified by Eating Habits Questionnaire)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Roasted snacks
Corn nuts
|
Roasted corn nut snack
|
|
Experimental: Roasted chickpeas
Chickpeas
|
Roasted chickpea snack
|
|
Experimental: Roasted yellow peas
Yellow peas
|
Roasted yellow pea snack
|
|
Experimental: Roasted pinto beans
Pinto beans
|
Roasted pinto bean snack
|
|
Experimental: Roasted soybeans
Soybeans
|
Roasted soybean snack
|
|
Experimental: Roasted almonds
Almonds
|
Roasted almond snack
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake
Time Frame: At 60 min
|
Ab libitum meal
|
At 60 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite
Time Frame: 0-200 min
|
Measured by VAS questionnaire at 12 time points used to calculate area under the curve
|
0-200 min
|
|
Blood glucose concentrations
Time Frame: 0-200 min
|
Measured in blood using a glucometer at 12 time points and used to calculate area under the curve
|
0-200 min
|
|
Physical comfort
Time Frame: 0-200 min
|
Measured by VAS questionnaire at 12 time points to calculate area under the curve
|
0-200 min
|
|
Energy and fatigue
Time Frame: 0-200 min
|
Measured by VAS questionnaire at 12 time points to calculate area under the curve
|
0-200 min
|
|
Palatability of meal
Time Frame: At 60 min
|
Measured by VAS questionnaire
|
At 60 min
|
|
Palatability of treatment
Time Frame: At 5 min
|
Measured by VAS questionnaire
|
At 5 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter JH Jones, PhD, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2017
Primary Completion (Actual)
April 4, 2018
Study Completion (Actual)
April 4, 2018
Study Registration Dates
First Submitted
July 6, 2017
First Submitted That Met QC Criteria
July 19, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS20792 (B2017:059)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual participant data requests should be submitted to the PI.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
Carmen Lucas AbellánUniversidad Católica San Antonio de MurciaCompletedOverweight/Obesity | Overweight or Obese | Overweight or Obese Adults | Obesity and Overweight | Obese SubjectsSpain
-
Empros Pharma ABNot yet recruitingOverweight or Obese | Obesity and Overweight
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
Children's Hospital Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsActive, not recruitingOverweight and Obesity | Overweight, Childhood | Overweight, InfantFrance
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Medialis Ltd.RecruitingObesity & Overweight | Overweight (BMI > 25)United Kingdom
-
Federal University of Health Science of Porto AlegreCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Active, not recruitingObesity & Overweight | Overweight (BMI > 25)Brazil
Clinical Trials on Corn nuts
-
King's College LondonUnknown
-
John SievenpiperThe Physicians' Services Incorporated FoundationCompletedObesity | Overweight | Body Weight | Adiposity | Obesity, AbdominalCanada
-
San Diego State UniversityRecruiting
-
Monash UniversityCompleted
-
Purdue UniversityAlmond Board of CaliforniaCompletedGlucose Intolerance | Appetite Disorders | Lipid Metabolism Disorder | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Tufts UniversityBoston UniversityCompletedCardiovascular Diseases | Hypertension | Heart Disease | Endothelial Dysfunction | Vascular DiseaseUnited States
-
Raquel BallarinFaculdade de Medicina de Botucatu, UNESP, Botucatu, BrasilRecruitingObesity | Type 2 DiabetesBrazil
-
University of California, Los AngelesCompleted
-
University Hospital, LinkoepingCompletedHealthy SubjectsSweden
-
USDA Beltsville Human Nutrition Research CenterCompletedHealthy VolunteersUnited States