A FINEH Protein Trial - Part 1

Not Applicable

Completed

• Conditions: Obesity Prevention; Diabetes Prevention
• Interventions: Other: Control; Other: Hemp shake; Other: Soybean shake

• Registration Number: NCT02366598
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

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: 2014-12-08
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2017-09
• Status Verified: 2021-04
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control shake	Control	non-protein control shake, given once, at beginning of acute trial
40 g hemp protein shake	Hemp shake	Hemp protein shake, 40 grams, given once, at beginning of acute trial
40 g Soybean protein shake	Soybean shake	Soybean protein shake, 40 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
20g Hemp protein shake	Hemp shake	Hemp protein shake, 20 grams, given once at beginning of acute trial

Primary Outcome Measures

Name	Time	Method
Food intake	0-200 min	Ad-libitum meal
Blood glucose concentration	0-200 min	Measured in blood by glucometer
Appetite	0-200 min	Measured by VAS Questionnaire
Blood pressure	0-200 min	Measured by automated bood pressure cuff

Secondary Outcome Measures

Name	Time	Method
Energy/fatigue	0 - 200 min	Measured by VAS questionnaire
Palatability of treatments and meal	5 -80 minutes	Measured by VAS questionnaire
Physical comfort	0 - 200 min	Measured by VAS questionnaire

Trial Locations

Locations (1)

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