Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2016
CompletedMarch 23, 2023
April 1, 2021
1 year
May 27, 2015
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Appetite
Measured by VAS Questionnaire.
0-200 minutes
Food Intake
Measured by fixed energy meal.
0-200 minutes
Blood Pressure
Measured by automated bood pressure cuff.
0-200 minutes
Secondary Outcomes (3)
Palatability of Treatments and Meal
5-80 minutes
Physical Comfort
0-200 minutes
Energy/Fatigue
0-200 minutes
Study Arms (5)
20g Hemp Protein Shake
EXPERIMENTALHemp protein shake, 20 grams, given once at beginning of acute trial.
40 g Hemp Protein
EXPERIMENTALHemp protein shake, 40 grams, given once, at beginning of acute trial.
20 g Soybean Protein Shake
ACTIVE COMPARATORSoybean protein shake, 20 grams, given once, at beginning of acute trial.
40 g Soybean Protein
EXPERIMENTALSoybean protein shake, 40 grams, given once, at beginning of acute trial.
Control Shake
PLACEBO COMPARATORNon-protein control shake, given once, at beginning of acute trial.
Interventions
Eligibility Criteria
You may qualify if:
- Normoglycemic (\<5.6 mmol/L)
- Body mass index (BMI) of 18.5-29.9 kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Manitoba Harvestcollaborator
Study Sites (1)
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Jones, Ph.D.
University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
May 29, 2015
Study Start
July 1, 2015
Primary Completion
July 13, 2016
Study Completion
July 13, 2016
Last Updated
March 23, 2023
Record last verified: 2021-04