A FINEH Protein Trial - Part 1

NCT02366598 | Completed

• 1 other identifier: B2014:115
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Prevention; Obesity Prevention

Outcome Measures

Primary Outcomes (4)

• Blood glucose concentration

  Measured in blood by glucometer

  0-200 min

• Appetite

  Measured by VAS Questionnaire

  0-200 min

• Food intake

  Ad-libitum meal

  0-200 min

• Blood pressure

  Measured by automated bood pressure cuff

  0-200 min

Secondary Outcomes (3)

• Palatability of treatments and meal

  5 -80 minutes

• Physical comfort

  0 - 200 min

• Energy/fatigue

  0 - 200 min

Study Arms (5)

20g Hemp protein shake

EXPERIMENTAL

Hemp protein shake, 20 grams, given once at beginning of acute trial

Other: Hemp shake

40 g hemp protein shake

EXPERIMENTAL

Hemp protein shake, 40 grams, given once, at beginning of acute trial

Other: Hemp shake

20 g Soybean protein shake

ACTIVE COMPARATOR

Soybean protein shake, 20 grams, given once, at beginning of acute trial

Other: Soybean shake

40 g Soybean protein shake

EXPERIMENTAL

Soybean protein shake, 40 grams, given once, at beginning of acute trial

Other: Soybean shake

Control shake

PLACEBO COMPARATOR

non-protein control shake, given once, at beginning of acute trial

Other: Control

Interventions

Hemp shake OTHER

Hemp protein shake

20g Hemp protein shake; 40 g hemp protein shake

Soybean shake OTHER

Soybean protein shake

20 g Soybean protein shake; 40 g Soybean protein shake

Control OTHER

Non-protein shake

Control shake

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Harvest: collaborator

Study Sites (1)

Richardson Centre for Functional Foods

Winnipeg, Manitoba, R3T2N2, Canada

Location

Study Officials

• Peter JH Jones, PhD

  University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: February 19, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2017
• Last Updated: March 17, 2023

Record last verified: 2021-04

Locations

CA (1)