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

Not Applicable

Completed

• Conditions: Obesity Prevention; Diabetes Prevention
• Interventions: Dietary Supplement: Hemp Shake; Dietary Supplement: Soybean Shake; Dietary Supplement: Soybean; Dietary Supplement: Control; Dietary Supplement: Hemp

• Registration Number: NCT02458027
• Lead Sponsor: University of Manitoba

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Study Start: 2015-07
• Primary Completion: 2016-07-13
• Study Completion: 2016-07-13
• Status Verified: 2021-04
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Normoglycemic (<5.6 mmol/L)
• Body mass index (BMI) of 18.5-29.9 kg/m2.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
20g Hemp Protein Shake	Hemp Shake	Hemp protein shake, 20 grams, given once at beginning of acute trial.
20 g Soybean Protein Shake	Soybean Shake	Soybean protein shake, 20 grams, given once, at beginning of acute trial.
40 g Soybean Protein	Soybean	Soybean protein shake, 40 grams, given once, at beginning of acute trial.
Control Shake	Control	Non-protein control shake, given once, at beginning of acute trial.
40 g Hemp Protein	Hemp	Hemp protein shake, 40 grams, given once, at beginning of acute trial.

Primary Outcome Measures

Name	Time	Method
Plasma Glucose and Insulin Concentrations	0-200 minutes	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)
Food Intake	0-200 minutes	Measured by fixed energy meal.
Blood Pressure	0-200 minutes	Measured by automated bood pressure cuff.
Appetite	0-200 minutes	Measured by VAS Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Palatability of Treatments and Meal	5-80 minutes	Measured by VAS Questionnaire.
Physical Comfort	0-200 minutes	Measured by VAS Questionnaire.
Energy/Fatigue	0-200 minutes	Measured by VAS Questionnaire.

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada