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PERFECT Project - Part 1 - Study 1

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402504
Enrollment
30
Registered
2015-03-30
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Prevention, Obesity Prevention

Brief summary

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.

Interventions

OTHERControl

Non pulse extruded snack

Pulse extruded snack

Pulse extruded snack

Pulse extruded snack

Pulse extruded snack

Pulse extruded snack

Sponsors

Saskatchewan Pulse Growers
CollaboratorOTHER
Alberta Pulse Growers
CollaboratorOTHER
University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Glucose and Insulin Concentrations0 - 200 minMeasured 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)
Food Intakeat 120 minAd-libitum meal
Subjective Appetite0-200 minMeasured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)

Secondary

MeasureTime frameDescription
Palatability of treatmentsat 5 minutesMeasured by VAS questionnaire
Physical Comfort0-200 minMeasured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure)
Palatability of mealat 140 minutesMeasured by VAS questionnaire
Energy and Fatigue0-200 minMeasured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026