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Completed

NCT Number: NCT02402504

PERFECT Project - Part 1 - Study 1

The objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

The investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.

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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

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) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg)
  • 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
  • Competitive sports or athletic training at a high intensity
  • Those unable to walk for an hour continuously

Treatment and study plan

Control

Other

Non pulse extruded snack

Small particle size pea flour

Other

Pulse extruded snack

Large particle size pea flour

Other

Pulse extruded snack

Lentil flour

Other

Pulse extruded snack

Navy bean flour

Other

Pulse extruded snack

Pinto bean flour

Other

Pulse extruded snack

Primary outcomes

  1. Plasma Glucose and Insulin Concentrations

    Time frame: 0 - 200 min

    Measured in blood using intravenous catheter at 12 time points and 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. Food Intake

    Time frame: at 120 min

    Ad-libitum meal

  3. Subjective Appetite

    Time frame: 0-200 min

    Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)

Secondary outcomes

  1. Palatability of treatments

    Time frame: at 5 minutes

    Measured by VAS questionnaire

  2. Palatability of meal

    Time frame: at 140 minutes

    Measured by VAS questionnaire

  3. Energy and Fatigue

    Time frame: 0-200 min

    Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure)

  4. Physical Comfort

    Time frame: 0-200 min

    Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure)

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Alberta Pulse Growers
  • Saskatchewan Pulse Growers

Registry information

Official study title

Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 1

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 30, 2015
Registry last updated
Jan 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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