Obesity Prevention Clinical Trial
Official title:
Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 1
NCT number | NCT02402504 |
Other study ID # | B2014:114-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | December 2017 |
Verified date | April 2021 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. The investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg) - BMI of 18.5-29.9 kg/m2 Exclusion Criteria: - Restrained eaters - Regularly skip breakfast - Smokers - Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year - Competitive sports or athletic training at a high intensity - Those unable to walk for an hour continuously |
Country | Name | City | State |
---|---|---|---|
Canada | Richardson Centre for Functional Foods and Nutraceuticals | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Alberta Pulse Growers, Saskatchewan Pulse Growers |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma Glucose and Insulin Concentrations | Measured in blood using intravenous catheter at 12 time points and used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits (Composite measure) | 0 - 200 min | |
Primary | Food Intake | Ad-libitum meal | at 120 min | |
Primary | Subjective Appetite | Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure) | 0-200 min | |
Secondary | Palatability of treatments | Measured by VAS questionnaire | at 5 minutes | |
Secondary | Palatability of meal | Measured by VAS questionnaire | at 140 minutes | |
Secondary | Energy and Fatigue | Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure) | 0-200 min | |
Secondary | Physical Comfort | Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure) | 0-200 min |
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