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OpenTrials
Completed

NCT Number: NCT02366598

A FINEH Protein Trial - Part 1

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.

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Key information

Conditions

Diabetes Prevention Obesity Prevention

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods

Winnipeg, Manitoba, R3T2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemp shake

Other

Hemp protein shake

Soybean shake

Other

Soybean protein shake

Control

Other

Non-protein shake

Primary outcomes

  1. Blood glucose concentration

    Time frame: 0-200 min

    Measured in blood by glucometer

  2. Appetite

    Time frame: 0-200 min

    Measured by VAS Questionnaire

  3. Food intake

    Time frame: 0-200 min

    Ad-libitum meal

  4. Blood pressure

    Time frame: 0-200 min

    Measured by automated bood pressure cuff

Secondary outcomes

  1. Palatability of treatments and meal

    Time frame: 5 -80 minutes

    Measured by VAS questionnaire

  2. Physical comfort

    Time frame: 0 - 200 min

    Measured by VAS questionnaire

  3. Energy/fatigue

    Time frame: 0 - 200 min

    Measured by VAS questionnaire

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Harvest

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Feb 19, 2015
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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