PERFECT Project - Part 2 - Study 1

NCT02402517 | Completed

• 1 other identifier: B2014:114-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Obesity

Keywords

Diabetes Prevention; Obesity Prevention

Outcome Measures

Primary Outcomes (4)

• Plasma Glucose and Insulin Concentrations

  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)

  0 - 240 min

• Food Intake

  Ad-libitum meal. Food consumed measured by weight.

  at 120 min

• Subjective Appetite

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

  0-240 min

• Exercise intensity

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

  60 minutes

Secondary Outcomes (7)

• Lactate concentration

  60 minutes

• Palatability of treatments

  at 5 minutes

• Palatability of meal

  at 260 minutes

• Physical comfort

  0-240 min

• Energy/fatigue

  0-240 min

Study Arms (6)

Extruded snack control

PLACEBO COMPARATOR

100% corn flour

Other: Control

Extruded snack with small particle size pea flour

EXPERIMENTAL

60% corn flour and 40% small particle size pea flour

Other: Small particle size pea flour

Extruded snack with large particle size pea flour

EXPERIMENTAL

60% corn flour and 40% large particle size pea flour

Other: Large particle size pea flour

Extruded snack with lentil flour

EXPERIMENTAL

60% corn flour and 40% lentil flour

Other: Lentil flour

Extruded snack navy bean flour

EXPERIMENTAL

60% corn flour and 40% navy bean flour

Other: Navy bean flour

Extruded snack with pinto bean flour

EXPERIMENTAL

60% corn flour and 40% pinto bean flour

Other: Pinto bean flour

Interventions

Control OTHER

Non pulse extruded snack

Extruded snack control

Small particle size pea flour OTHER

Pulse extruded snack

Extruded snack with small particle size pea flour

Large particle size pea flour OTHER

Pulse extruded snack

Extruded snack with large particle size pea flour

Lentil flour OTHER

Pulse extruded snack

Extruded snack with lentil flour

Navy bean flour OTHER

Pulse extruded snack

Extruded snack navy bean flour

Pinto bean flour OTHER

Pulse extruded snack

Extruded snack with pinto bean flour

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Saskatchewan Pulse Growers: collaborator
• Alberta Pulse Growers: collaborator

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter JH Jones, PhD

  University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: March 30, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2023

Record last verified: 2017-05

Locations

CA (1)