Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2

Study Overview
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Brief Summary
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The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the second meal effect of hemp protein versus soybean protein and a non-protein control.

Detailed Description
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The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the second meal effect of hemp protein versus soybean protein and a non-protein control. The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the second meal effect of hemp protein versus soybean protein and a non-protein control.

Official Title
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Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2 - Are Acute Effects of Hemp Protein on Blood Glucose and Appetite Insulin-dependent?

Conditions
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Diabetes Prevention, Obesity Prevention

Intervention / Treatment
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* Dietary Supplement: Hemp Shake
* Dietary Supplement: Hemp
* Dietary Supplement: Soybean Shake
* Dietary Supplement: Soybean
* Dietary Supplement: 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. 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.

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: Single


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. | Dietary Supplement: Hemp Shake<br>* Hemp Protein<br>|
| Experimental: 40 g Hemp Protein<br>Hemp protein shake, 40 grams, given once, at beginning of acute trial. | Dietary Supplement: Hemp<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. | Dietary Supplement: Soybean Shake<br>* Soybean Protein<br>|
| Experimental: 40 g Soybean Protein<br>Soybean protein shake, 40 grams, given once, at beginning of acute trial. | Dietary Supplement: Soybean<br>* Soybean Protein Shake<br>|
| Placebo Comparator: Control Shake<br>Non-protein control shake, given once, at beginning of acute trial. | Dietary Supplement: Control<br>* Non-Protein Shake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose and Insulin Concentrations | Measured in blood using intravenous catheter at 12 time points, 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 minutes | 
| Appetite | Measured by VAS Questionnaire. | 0-200 minutes | 
| Food Intake | Measured by fixed energy meal. | 0-200 minutes | 
| Blood Pressure | Measured by automated bood pressure cuff. | 0-200 minutes | 

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 minutes | 
| Energy/Fatigue | Measured by VAS Questionnaire. | 0-200 minutes |