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Completed

NCT Number: NCT02370927

PERFECT Project - Part 2 - Study 2

The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals 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 cereals containing pulse ingredients 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)
  • Body Mass Index 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
  • Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity)
  • Those unable to walk for an hour continuously

Treatment and study plan

Control

Other

Non pulse extruded cereal

Pea protein

Other

Pulse extruded cereal

Pea Starch

Other

Pulse extruded cereal

Pea fibre + pea starch

Other

Pulse extruded cereal

Pea protein + pea starch

Other

Pulse extruded cereal

Pea fibre + pea starch + pea protein

Other

Pulse extruded cereal

Primary outcomes

  1. Plasma Glucose Concentrations

    Time frame: 0-240 minutes

    Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer,

  2. Food Intake

    Time frame: at 240 minutes

    Ad-libitum meal

  3. Subjective Appetite

    Time frame: 0-240 minutes

    Motivation-to-eat Visual Analog Scale questionnaire

  4. Exercise intensity

    Time frame: 60-120 minutes

    Oxygen consumption measured during exercise at 3 time points

  5. Insulin concentrations

    Time frame: 0-240 minutes

    Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits

Secondary outcomes

  1. Palatability measured by Visual Analog Scale questionnaire

    Time frame: 5 and 260 minutes

    Food tasting

  2. Physical comfort measured by Visual Analog Scale questionnaire

    Time frame: 0-240 minutes

    Contributions from energy intake

  3. Energy/fatigue measured by Visual Analog Scale questionnaire

    Time frame: 0 - 240 minutes

    Estimate of energy expenditure

  4. Heart rate

    Time frame: 60-120 minutes

    To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)

  5. Substrate Oxidation

    Time frame: 60-120 minutes

    Respiratory quotient measured during exercise at 3 time points

  6. Lactate concentration

    Time frame: 60-120 minutes

    Measured before, during, and after exercise 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 2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Jan 26, 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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