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Completed

NCT Number: NCT02458027

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

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.

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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 and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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.

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.

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.

Treatment and study plan

Hemp Shake

Dietary Supplement

Hemp Protein

Hemp

Dietary Supplement

Hemp Protein Shake

Soybean Shake

Dietary Supplement

Soybean Protein

Soybean

Dietary Supplement

Soybean Protein Shake

Control

Dietary Supplement

Non-Protein Shake

Primary outcomes

  1. Plasma Glucose and Insulin Concentrations

    Time frame: 0-200 minutes

    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)

  2. Appetite

    Time frame: 0-200 minutes

    Measured by VAS Questionnaire.

  3. Food Intake

    Time frame: 0-200 minutes

    Measured by fixed energy meal.

  4. Blood Pressure

    Time frame: 0-200 minutes

    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 minutes

    Measured by VAS Questionnaire.

  3. Energy/Fatigue

    Time frame: 0-200 minutes

    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 2 - Are Acute Effects of Hemp Protein on Blood Glucose and Appetite Insulin-dependent?

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
Mar 23, 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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