A FINEH Protein Trial - Part 1

Study Overview
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Brief Summary
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The objectives of this trial are to assess the health benefits of acute hemp protein consumption compared to soybean protein and a non-protein control on: 1) blood glucose, appetite and blood pressure for one hour following consumption, 2) food intake at an ad libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure following the ad libitum meal to determine the second meal effect of hemp protein.

Official Title
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Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 1 - Acute Effects of Hemp Protein on Blood Glucose, Appetite, Blood Pressure and Food Intake.

Conditions
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Diabetes Prevention, Obesity Prevention

Intervention / Treatment
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* Other: Hemp shake
* Other: Soybean shake
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normoglycemic (<5.6 mmol/L) Body mass index (BMI) of 18.5-29.9 kg/m2 Participants will be excluded if they regularly skip breakfast, smoke, or consuming medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year. Exclusion Criteria: Restrained eaters Regularly skip breakfast Smokers Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity) Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20g Hemp protein shake<br>Hemp protein shake, 20 grams, given once at beginning of acute trial | Other: Hemp shake<br>* Hemp protein shake<br>|
| Experimental: 40 g hemp protein shake<br>Hemp protein shake, 40 grams, given once, at beginning of acute trial | Other: Hemp shake<br>* Hemp protein shake<br>|
| Active Comparator: 20 g Soybean protein shake<br>Soybean protein shake, 20 grams, given once, at beginning of acute trial | Other: Soybean shake<br>* Soybean protein shake<br>|
| Experimental: 40 g Soybean protein shake<br>Soybean protein shake, 40 grams, given once, at beginning of acute trial | Other: Soybean shake<br>* Soybean protein shake<br>|
| Placebo Comparator: Control shake<br>non-protein control shake, given once, at beginning of acute trial | Other: Control<br>* Non-protein shake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentration | Measured in blood by glucometer | 0-200 min | 
| Appetite | Measured by VAS Questionnaire | 0-200 min | 
| Food intake | Ad-libitum meal | 0-200 min | 
| Blood pressure | Measured by automated bood pressure cuff | 0-200 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of treatments and meal | Measured by VAS questionnaire | 5 -80 minutes | 
| Physical comfort | Measured by VAS questionnaire | 0 - 200 min | 
| Energy/fatigue | Measured by VAS questionnaire | 0 - 200 min |