Overview

This trial is active, not recruiting.

Conditions diabetes prevention, obesity prevention
Treatments hemp shake, soybean shake, control
Sponsor University of Manitoba
Collaborator Manitoba Harvest
Start date May 2015
End date December 2015
Trial size 30 participants
Trial identifier NCT02366598, B2014:115

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Hemp protein shake, 20 grams, given once at beginning of acute trial
hemp shake
Hemp protein shake
(Experimental)
Hemp protein shake, 40 grams, given once, at beginning of acute trial
hemp shake
Hemp protein shake
(Active Comparator)
Soybean protein shake, 20 grams, given once, at beginning of acute trial
soybean shake
Soybean protein shake
(Experimental)
Soybean protein shake, 40 grams, given once, at beginning of acute trial
soybean shake
Soybean protein shake
(Placebo Comparator)
non-protein control shake, given once, at beginning of acute trial
control
Non-protein shake

Primary Outcomes

Measure
Blood glucose concentration
time frame: 0-200 min
Appetite
time frame: 0-200 min
Food intake
time frame: 0-200 min
Blood pressure
time frame: 0-200 min

Secondary Outcomes

Measure
Palatability of treatments and meal
time frame: 5 -80 minutes
Physical comfort
time frame: 0 - 200 min
Energy/fatigue
time frame: 0 - 200 min

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

Official title 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.
Principal investigator Peter JH Jones, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Manitoba.