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 July 2015
End date July 2016
Trial size 15 participants
Trial identifier NCT02458027, B2014:115-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
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
Plasma Glucose and Insulin Concentrations
time frame: 0-200 minutes
Appetite
time frame: 0-200 minutes
Food Intake
time frame: 0-200 minutes
Blood Pressure
time frame: 0-200 minutes

Secondary Outcomes

Measure
Palatability of Treatments and Meal
time frame: 5-80 minutes
Physical Comfort
time frame: 0-200 minutes
Energy/Fatigue
time frame: 0-200 minutes

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. 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.

Additional Information

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