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

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?

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Prevention; Obesity Prevention
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Hemp Shake; Dietary supplement: Hemp; Dietary supplement: Soybean Shake; Dietary supplement: Soybean

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

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.

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.

Study Plan

How is the study designed?

Design Details

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

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.	Dietary supplement: Hemp Shake; Hemp Protein
Active Comparator: 20 g Soybean Protein Shake; Soybean protein shake, 20 grams, given once, at beginning of acute trial.	Dietary supplement: Soybean Shake; Soybean Protein
Placebo Comparator: Control Shake; Non-protein control shake, given once, at beginning of acute trial.	Dietary supplement: Control; Non-Protein Shake
Experimental: 40 g Hemp Protein; Hemp protein shake, 40 grams, given once, at beginning of acute trial.	Dietary supplement: Hemp; Hemp Protein Shake
Experimental: 40 g Soybean Protein; Soybean protein shake, 40 grams, given once, at beginning of acute trial.	Dietary supplement: Soybean; Soybean Protein Shake

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Harvest
• Investigators: Principal Investigator: Peter Jones, Ph.D., University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 13, 2016
• Study Completion (Actual): July 13, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B2014:115-3