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

NCT ID: NCT02458027

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Prevention Obesity Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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20g Hemp Protein Shake

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

Group Type EXPERIMENTAL

Hemp Shake

Intervention Type DIETARY_SUPPLEMENT

Hemp Protein

40 g Hemp Protein

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

Group Type EXPERIMENTAL

Hemp

Intervention Type DIETARY_SUPPLEMENT

Hemp Protein Shake

20 g Soybean Protein Shake

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

Group Type ACTIVE_COMPARATOR

Soybean Shake

Intervention Type DIETARY_SUPPLEMENT

Soybean Protein

40 g Soybean Protein

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

Group Type EXPERIMENTAL

Soybean

Intervention Type DIETARY_SUPPLEMENT

Soybean Protein Shake

Control Shake

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Non-Protein Shake

Interventions

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Hemp Shake

Hemp Protein

Intervention Type DIETARY_SUPPLEMENT

Hemp

Hemp Protein Shake

Intervention Type DIETARY_SUPPLEMENT

Soybean Shake

Soybean Protein

Intervention Type DIETARY_SUPPLEMENT

Soybean

Soybean Protein Shake

Intervention Type DIETARY_SUPPLEMENT

Control

Non-Protein Shake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Manitoba Harvest

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Jones, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

Locations

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Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2014:115-3

Identifier Type: -

Identifier Source: org_study_id

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