A FINEH Protein Trial - Part 1

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Prevention; Obesity Prevention
• Intervention / Treatment: Other: Hemp shake; Other: Soybean shake; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T2N2
      • Richardson Centre for Functional Foods

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Harvest

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B2014:115