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

Obesity Prevention Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458027
• Other study ID #: B2014:115-3
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 13, 2016

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 13, 2016
• Est. primary completion date: July 13, 2016
• 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.

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.

Related Conditions & MeSH terms

• Diabetes Prevention
• Obesity Prevention

Intervention

Dietary Supplement:
• Hemp Shake
Hemp Protein
• Hemp
Hemp Protein Shake
• Soybean Shake
Soybean Protein
• Soybean
Soybean Protein Shake
• Control
Non-Protein Shake

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	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	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
Primary	Appetite	Measured by VAS Questionnaire.	0-200 minutes
Primary	Food Intake	Measured by fixed energy meal.	0-200 minutes
Primary	Blood Pressure	Measured by automated bood pressure cuff.	0-200 minutes
Secondary	Palatability of Treatments and Meal	Measured by VAS Questionnaire.	5-80 minutes
Secondary	Physical Comfort	Measured by VAS Questionnaire.	0-200 minutes
Secondary	Energy/Fatigue	Measured by VAS Questionnaire.	0-200 minutes