A FINEH Protein Trial - Part 1

Obesity Prevention Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366598
• Other study ID #: B2014:115
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Prevention
• Obesity Prevention

Intervention

Other:
• Hemp shake
Hemp protein shake
• Soybean shake
Soybean protein shake
• Control
Non-protein shake

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Harvest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose concentration	Measured in blood by glucometer	0-200 min
Primary	Appetite	Measured by VAS Questionnaire	0-200 min
Primary	Food intake	Ad-libitum meal	0-200 min
Primary	Blood pressure	Measured by automated bood pressure cuff	0-200 min
Secondary	Palatability of treatments and meal	Measured by VAS questionnaire	5 -80 minutes
Secondary	Physical comfort	Measured by VAS questionnaire	0 - 200 min
Secondary	Energy/fatigue	Measured by VAS questionnaire	0 - 200 min