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Completed

NCT Number: NCT02402517

PERFECT Project - Part 2 - Study 1

The objectives are to test the acute effects of different extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.

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Key information

Age range

18 year–50 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 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.
  • 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 - 240 min

    Measured in blood using intravenous catheter at 14 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. Food Intake

    Time frame: at 120 min

    Ad-libitum meal. Food consumed measured by weight.

  3. Subjective Appetite

    Time frame: 0-240 min

    Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure)

  4. Exercise intensity

    Time frame: 60 minutes

    Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points.

Secondary outcomes

  1. Lactate concentration

    Time frame: 60 minutes

    60 minute exercise protocol at minutes 60 to 120. Measured before, during, and exercise exercise at 3 time points

  2. Palatability of treatments

    Time frame: at 5 minutes

    Measured by VAS questionnaire

  3. Palatability of meal

    Time frame: at 260 minutes

    Measured by VAS questionnaire

  4. Physical comfort

    Time frame: 0-240 min

    Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)

  5. Energy/fatigue

    Time frame: 0-240 min

    Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)

  6. Heart rate

    Time frame: 60-120 min

    Heart rate monitored over a 60 minute exercise protocol. To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)

  7. Substrate Oxidation

    Time frame: 60 minutes

    Measured during 60 minute exercise protocol at minutes 60-120. Respiratory quotient measured during exercise at 3 time points.

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 2 - Acute Effects of Pulse Ingredients in Food Products on Aerobic Endurance and Substrate Oxidation During Exercise, as Well as, the Blood Glucose, Insulin, Lactate and Food Intake Response Following an Endurance Exercise Session in Adults - Study 1

Important dates

Study start
2015
Primary completion
2017
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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